Regulatory Affairs Manager In Mylan for B.Pharm, M.Pharm

Regulatory Affairs Manager In Mylan for B.Pharm, M.Pharm

Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.

Post

Manager – Regulatory Affaires

Job Description

• Developing good communication network with drug regulatory authorities and coordinating with drug authorities for the registration of drugs/ renewal of certificates
  
• Providing periodic updates of the interactions with the authorities
  
• Maintaining record of existing licenses & dates for renewal of each; applying for renewals well in time
  
• Preparing a framework with timelines for the registration of new products
  
• Reviewing and approve the artwork for label and cartons
  
• Prepare the prescribing information and abbreviated prescribing information for the products
  
• Having complete understanding of the drug laws existing in the country
  
• Developing & complying with local SOP
  

Qualifications

 
Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the qualifications for this position:

• Minimum 5-10 years Experience
  
• Bachelors degree in Pharmacy and Masters degree in Pharmarcy or Masters degree in Science
  

Additional Information:

 
Experience: 5-10 year

Location: Andhra Pradesh-Hyderabad

Industry Type: Pharma/Biotech/Clinical Research

Functional Area: R&D

End Date: 17^th Oct, 2013

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Production Officer Unit 7 in Mylan in Hyderabad

 Production Officer Unit 7 in Mylan in Hyderabad

Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.

Post: Officer (Prod), Unit 7

Job Description:

• Test raw materials, blends, intermediates and finished product to ensure a quality product that is safe to release to the public
  
• Review and process data. Interpret test results and ensure that they meet specification, enter data into the computer, maintain instrument logbooks, complete laboratory worksheets and all relevant documentation according to cGMP documentation practices, review all information and compile information into report form
  
• Act as a resource to team members and other Chemists
  
• Act as back-up in A Team Leader’s absence
  
• Review and approve paperwork and documentation from other chemists. Troubleshoot instrumentation and investigate aberrant test results.
  
• Perform analytical investigations. Activities include drafting Analytical Investigation Report text, performing action steps and drawing justifiable conclusions based on data.
  

Qualifications

 
Make Our Values Your Values

• Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications for this position:
  
• Minimum of a Bachelor of Science Degree in a related discipline and a minimum of 4-6 years of experience is required. However, a combination of experience and/or education will be taken into consideration.
  
• Must possess knowledge of Standard Operating Procedures, Mylan Laboratory Procedures, USP regulations, Analytical Testing Techniques, cGMP, and OSHA regulations/procedures for disposal of organic waste and procedures for the safe handling of chemicals
  
• Must possess excellent communication, writing, reading, comprehension, organizational and computer skills; including knowledge of Excel, Word, and Lotus Notes. Must be accurate, detailed oriented, possess the ability to multi-task and work in a fast paced, high output environment.
  

Additional Information:

 
Experience: 4-6 years

Location: Andhra Pradesh-Hyderabad

Industry Type: Pharma/Biotech/Clinical Research

Functional Area: Production

End Date: 15^th Oct., 2013

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Regulatory CMC Associate Manager-II in Novartis 2 posts Freshers may apply

Regulatory CMC Associate Manager-II in Novartis 2 posts Freshers may apply


A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Regulatory CMC Associate Manager-II

Job Description

 
The following tasks are to be performed as assigned:
1. Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.

2. Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle.

3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.

4. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.

5. Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.

6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

7. Establish and maintain sound working relationships with partners and customers.

8. Assume activities in support of the general department such as DRAGON sup-port, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database en-try activities (specialized department functions).

 

Candidate Profile

 
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. English
1. 0-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
2. Working knowledge of chemistry/biotechnology, analytics or phar-maceutical technology. Knowledge of the drug development pro-cess desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
3. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
4. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
5. Effective planning, organizational and interpersonal skills.
6. Reasonable approach to risk assessment.
7. Excellent written/spoken communication and negotiation skills.
8. Computer literacy.

Additional Information

 
Job ID: 125944BR, 125943BR

Experience: 0-4 Year

Industry Type: Pharma/Biotech/Clinical Research

Location: Hyderabad

Functional Area: Sales

End Date: 15^th Oct, 2013

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APPLY ONLINE- 125944BR

APPLY ONLINE- 125943BR

 

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Scientific And Compliance Manager Post in Novartis in Hyderabad

Scientific And Compliance Manager Post in Novartis in Hyderabad



A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post

Scientific And Compliance Manager

Job Description

 
The position provides a critical role in ensuring quality (scientific and editorial) deliverables of all projects being delivered by a Function. The role is responsible for scientific and compliance review of content developed by the Function ensuring high quality deliverables meeting customer expectations within timelines.
•To ensure and enable overall quality and compliance of scientific writing projects.
•To review, in collaboration with the writing team, all medical communication deliverables for clarity, consistency, grammar, syntax, writing style, data accuracy and meeting congress and journal requirements.
•To ensure that comments and feedback received from internal and external stakeholders and customer specifications for all documents delivered from a function are addressed appropriately and consistently.
•To provide coaching and training to medical writers and Group/Team Leaders on compliance and scientific quality.
•To track quality and drive consistency within and across Line Functions. Work closely with the FHs to identify training requirements and drive quality and compliance initiatives.
•To ensure deliverables are in compliance with Novartis internal writing specification tools and guidelines including
•To ensure that publications are consistent with GPP2- good publications practice; ICJME, Consort, and internal Novartis SOPS. •Working in collaboration with Function Heads responsible for updating any internal writing specification tools and guidelines. Exceptional written and oral communication, interpersonal, organizational, and problem-solving skills; attention to details.
• Exceptional ability to work collaboratively with teams, manage multiple projects, with changing priorities and specifications.
• Ability to work independently with limited supervision

Minimum requirements

 
Science degree or equivalent, B.Sc./equivalent with 8 years Clinical Research (CR) experience, M.Sc./M.Pharm +6 years of clinical research (CR) experience. Desired: Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent)- PhD + 4 year of CR experience, MBBS/equivalent + 4 year of CR experience, MD +2 years of CR experience At least 5 years’ experience in medical communications as a medical writer or editor. Excellent written and oral English language skills Science degree or equivalent, B.Sc./equivalent with 8 years Clinical Research (CR) experience, M.Sc./M.Pharm +6 years of clinical research (CR) experience. Desired: Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent)- PhD + 4 year of CR experience, MBBS/equivalent + 4 year of CR experience, MD +2 years of CR experience At least 5 years’ experience in medical communications as a medical writer or editor.

Additional Information

 
Job ID: 126975BR

Experience: 2-4

Location: Andhra Pradesh-Hyderabad

Industry Type: Pharma/Biotech/Clinical Research

Functional Area: CR

End Date: 21^th Oct, 2013

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Area Sales Executive in Panacea Biotec

Area Sales Executive in Panacea Biotec 


Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx.Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services.

 

Post: Area Sales Executive - Panacea OncoTrust / Nephrology / Transplant Business Unit

Job Description: 

 
The candidate should have at least one year of experience in Pharma sales in specialty division.
Candidate presently working with Super Specialty / Specialty Business or with Top MNC’s in Acute / Chronic / Pharma Business, wants to further pursue their career and passion to excel in Super Specialty Business
The candidate should be localite.
The candidate should have good communication skill.

Additional Information:

 
Experience: 15  Years

Age: 23-32 years

Location: Hyderabad, Nagpur, Lucknow, Patna, Bangalore, Delhi, Mumbai

Education: B.Sc, B. Pharma, M.Sc, M. Pharma, MBA

Industry Type: Pharma/Biotech/Vaccines

Functional Area: Sales

Last Date: 10^th Oct., 2013

Apply/Forward your Resume, saleshr@PANACEABIOTEC.COM

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Assistant Manager Post in Dr. Reddy’s Laboratories For M.Pharm and B.Pharm

Assistant Manager Post in Dr. Reddy’s Laboratories For M.Pharm and B.Pharm

 

Established in 1984, Dr. Reddy’s Laboratories (NYSE: RDY) is an emerging global pharmaceutical company. As a fully integrated pharmaceutical company, our purpose is to provide affordable and innovative medicines through our three core businesses.

Post: Assitant Manager

 

Job description

 
Role:Team Member Fill Finish Manufacturing
Key Responsibilities
1. Responsible for Sterile operation (formulation and filling).
2. Ensure adherence to c-GMP in Sterile operations.
3. Reasonable for execution of pre-defined monthly production schedule (prepared by planning group).
4. Coordinate routine production activity(including cross functional coordination) in sterile operations.
5. Ensure facility readiness (For Man, machine, material , utilities and facility) for campaign changeover or product change over.
6. Ensure timely closure of discrepancies, deviations, CAPA and internal audit CARS and implementation of change control.
7. Implementation of SHE Management System in manufacturing department.

Additional Information:

 
Experience: 4-7  Years

Location: Hyderabad

Education: M.Sc. - (Microbiology/ Biotechnology) or M.Pharm, B.Pharm

Industry Type: Pharma/Biotech/Vaccines

Last Date: 15^th Oct., 2013

APPLY ONLINE

 
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Freshers Job In Costarica pharmaceuticals for M.Pharma and B.Pharma in Hyderabad

 Freshers Job In Costarica pharmaceuticals for M.Pharma and B.Pharma in Hyderabad

M/S Costaricapharmaceuticals a Growing Pharmaceutical Company in India located at Hyderabad, Andhra Pradesh, engaged in the manufacturing, supplying and exporting a wide assortment of Non pearl seeds (Dummy Pellets), Multivitamins and sugar Pellets to our customers.

Post: M.Pharma/B.pharma, Bsc/MSc FRESHERS

Job Description: 

 
Preparation of SOP's & STP'S
Preparation of Process Validation Documentations
Preparation of dossiers,
All Qa related documentation preparations,
Involvement of IQ,OQ,PQ,
Support for internal and external audits Etc

we are looking for freshers only. don't apply experienced persons.

Additional Information:

 
Experience: Fresher

Job Location: Hyderabad

Industry Type: Pharma/ Biotech/Clinical Research

End Date: 26^th Sep, 2013

Contact Details:

 
COSTARICA PHARMACEUTICALS.
Plot no:51,
Aleap Industrial Area,
Designer Foods Building,
Near Pragathi Nagar,
Opp: JNTU, Kukatpally, Hyderabad

costaricapharma@gmail.com

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Analytical Scientist Post in Novartis Freshers may apply

Analytical Scientist Post in Novartis Freshers may apply


A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
 

Post: Analytical Scientist - I

Job Description

 
• Individually performs and manages innovation, method development, method validation under guidance.
• Independently performs prestability/ stability testing and all other analytical related activities for Global OTC products.
• Acquisition of all technical competencies required for analytical development at work.
• Participate in project teams and assist in troubleshoot and finding solutions.
• Conducts experiments, investigations, and special testing as needed for problem solving, to address regulatory issues, or to characterize drug substances/ drug products.

• Work closely with members of cross functional teams at different locations.
• Accountable for managing projects against timelines while maintaining high quality standards.
• Maintains GMP compliant, state-of-the-art analytical laboratories.
• Perform all laboratory work with proper planning and scheduling of jobs.
• Accountable for consistently meeting the targets and KPI’s for self.
Key Distinguishing Responsibilities
• Follow GMPs, SOPs, HSE requirements and other applicable regulations.
• Performs analytical method development, method validation and Method Transfers under
supervision.
• Write / Review SOPs, qualification documents and protocols & reports of method development,
method validation and method transfer.
• Review laboratory notebooks (routine testing).
• Execution of Prestability / GMP Stability samples and maintenance of laboratory database.
• Suggest potential equipment needed for analytical development.
• Trouble shoot scientific and instrument related challenges with limited supervision.
• Train associates on analytical methods and instrumentation case by case basis. Keep abreast on the latest changes in analytical science with limited supervision.
• Desired knowledge of chemical principles, analytical techniques, analytical instrumentation, GxPs, validation and allied areas.
• Current knowledge of chemical and Analytical sciences is desirable.
• Good communication skills.
• Experience in managing analytical or stability projects is desirable.
• Ability to solve complex scientific problems.
• Computational skills.
• Sound working knowledge of Computers.

Experience

 
• MSc / M Pharm with 0 - 2 years of relevant experience.

Additional Information:

 
Experience: 0-2 Years

Location: Hyderabad

Education: M.Sc, M.Pharm

Industry Type: Pharma/ Biotech/Clinical Research

Functional Area: R&D

 
Division: Pharma

Job Type: Full Time

 
Employment Type: Permanent

Job ID: 126818BR

End Date: 24^th Sep., 2013 (APPLY NOW, POSITION MAY CLOSE TODAY ITSELF)

 

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Production Chemist In Unit 3 in Mylan For B.pharm and M.pharm

Production Chemist In Unit 3 in Mylan For B.pharm and M.pharm

Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline.

Post: Chemist - Production - Unit - 3

Qualifications

 
Education:

 
API: Graduate in science

FDF: Graduate in pharmacy

Experience:

 
API: Minimum of  2 years of experience in API manufacturing / chemical industry
FDF: Fresher/ 1 year of experience with exposure to (formulation manufacturing preferred)

Competencies:

 
- Knowledge of production technologies and quality systems
- Knowledge of regulatory and GMP guidelines
- Knowledge of EHS requirements

Additional Information:

 
Experience: 1-2 year

Location: Andhra Pradesh-Hyderabad

Industry Type: Pharma/Biotech/Clinical Research

Functional Area: Production

End Date: 30^th Sep, 2013

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BHEL Recruitment 2013 For Artisans 800 Posts

BHEL Recruitment 2013 For Artisans 800 Posts

 

 

 

Bharat Heavy Electricals Limited (BHEL) has released latest Recruitment Notification 2013 for 800 Posts of Artisans vacancies. Interested and deserving candidates have to apply online on or before 05/10/013. BHEL Recruitment 2013 details is mentioned below.

BHEL Recruitment 2013 Vacancy Details

1. Machinist: 245 Posts
2. Turner: 164 Posts
3. Fitter: 285 Posts
4. Blacksmith: 05 Posts
5. Welder: 59 Posts
6. Carpenter: 05 Posts
7. Electrician: 37 Posts

Age Limit: 27 years

Educational Qualification : Metric/SSC with National Trade Certificate [NTC] & National Apprenticeship Certificate [NAC] in the respective trade.

Application Fees : Rs.125/- (SC/ ST Candidates are Exempted from Application fee)

Last Date : 05/10/2013

How to Apply: Eligible & Interested Candidates may fill the online application in the website http://www.bhel.com  from 14/09/2013 to 05/10/2013.

For Detailed Notification : http://recruit.bhelhyd.co.in/formats/advt.pdf

Apply Online : http://www.bhelhyderabad.com/

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CMU Production Officer Post in Mylan Freshers May apply

CMU Production Officer Post in Mylan Freshers May apply

Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product.

Post: Officer CMU Production-UNIT-1

Areas of Responsibility

 
1. Responsible for execution of new and campaign products at new/existing CMUs for validations
2. Responsible for coordinating the audits during qualification of new CMUs and periodical stock audits
3. Responsible for Monthly Legacy statements and SAP adjustments.
4. Responsible for carrying out the Quarterly stock audit at respective CMUs.
5. Responsible for monitoring the batches at CMUs on a regular basis
6. Responsible for creation of Subcontracting POs in SAP.
7. Responsible to co - ordination in Operational Excellence.
8. Responsible for carrying out the OOS investigations at CMU sites.
9. Responsible for site audit for new CMU Qualification of solvents/Intermediate at Various CMUs.
10. Responsible for training the GMP, Safety & trouble shooting at CMUs.
11. Any other job assigned by the department in charge.

Qualifications

 
Education:
API: Graduate in science
FDF: Graduate in pharmacy

Experience

 
API: Minimum of  2 years of experience in API manufacturing / chemical industry
FDF: Fresher/ 1 year of experience with exposure to (formulation manufacturing preferred)

Competencies

 
- Knowledge of production technologies and quality systems
- Knowledge of regulatory and GMP guidelines
- Knowledge of EHS requirements

Additional Information:

 
Experience: 1-2 year

Location: Andhra Pradesh-Hyderabad

Functional Area: Production

Industry Type: Pharma/Biotech/Clinical Research

End Date: 11^th Oct, 2013

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Clinical Data Manager Post in Novartis In Hyderabad

Clinical Data Manager Post in Novartis In Hyderabad


A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Clinical Data Manager

Job Description:

Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines.

1.Provide professional DM input on Clinical Trial Team(s)
2.Input to and review of clinical trial database design including User Acceptance Testing (UAT).
3.Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
4.Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.
5.Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
6.Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
7.Support and provide leadership for data management staff for allocated trials.
8.Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
9.Perform training on data management software and practices or trial specific topics as required.
10.Prepare training materials for data management activities and processes as required.
11.Travel is required as needed.

Candidate Profile:

  University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).
1.2 or more years experience in drug development with at least 2 years experience in Data Manage-ment.
2.University Science Degree in life sciences, pharmacy, nursing or equivalent relevant experience.
3.Excellent written and oral English skills
4.Understanding of clinical trial methodology, GCP and medical terminology
5.Good computer skills
6.Good organizational and project management skills.
7.Good communication and interpersonal skills
8.Intermediate presentation and problem solving skills
9.Ability to work well in a team
10.May coordinate and provide direction on task to other data management team members

Additional Information:

 
Location: Hyderabad

Industry Type: Pharma/ Biotech/Clinical Research

Functional Area: CR

 
Division: Pharma

Job Type: Full Time

 
Employment Type: Permanent

End Date: 30^th Aug, 2013

To Apply CLICK HERE

 

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