Teva Quality Analyst III 

India, Karnataka, Bengaluru 

565534442

• The jobholder acts as a member of Teva External Manufacturing & Supply Organization (EMSO)
• Jobholder closely interacts with the Team Leader and the QRM’s and if required other departments such as Procurement, Supply Chain, MS&T, and Regulatory Affairs and provides complete support from quality perspective.
• The position is to handle to review the QMS documents associated with formulations that include various dosage forms of products supplied to EMSO. The market is primarily for US, EU and Canada.
• The jobholder will be responsible for review of QMS documents and ensuring that the Supply is not interrupted due to the delay and provides timely updates on the status of the QMS documents.
• Responsible to follow the Quality Management System of EMSO organization, which is relevant to the job function
• Review of Analytical related documents
• Review of Analytical Method validation and reports
• Pharmacopeial and CEP Updates
• Nitrosamine Risk assessment

1. Change Controls and Investigations:

• Review of change controls related to Excipient, API, FP Specification/ STP revisions.
• Review of investigations pertaining to laboratory - OOS/OOT

2. Analytical Method Validation:

• Review of documents related to Analytical Method Validation, Method Transfer and Verifications.
• Review and providing inputs on all Analytical documents inline with regulatory requirements
• Responsible to ensure method transfer, method validation and equivalency of new product against USP monograph.

3. Pharmacopeial and CEP Updates:

• Knowledge on current pharmacopeial and CEP Updates.
• Responsible for ensuring any impact to the Analytical Documents against current USP.

4. Nitrosamine Risk assessment

• Review of NRA and further actions inline with compliance requirements

5. Training system Management: Ensure training completion in LMS and management of training records.
6. KPI Data management:

• Ensure KPI metrics are met as per acceptance criteria for the Quality.

7. Any other responsibilities as assigned by the supervisor from time to time.

• M. Pharm / M.Sc. (Science), B. Pharm
• Pharmaceutical Sciences / Life Sciences
• Minimum 8 - 12 years of experience in pharmaceutical industry
• Experience of handling Analytical QC activities and External / Contract manufacturing sites.
• Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment
• Knowledge on Compliance Standards and Regulation as applicable to the market.
• Experience of handling Analytical QC activities and External / Contract manufacturing sites.
• Knowledge and working experience with USFDA / EU and other competent authority approved sites.
  

Associate Director, Quality Assurance

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