Greetings from Aurobindo Pharma Limited, We are hiring SENIOR MANAGER / ASSISTANT GENERAL MANAGER in Quality Department for a Greenfield Project at #Kakinada Location. #api #hiring #pharmaceutical #qualityassurance #qualitycontrol #aurobindo #pharma #microbiology #quality #pharma #Hiring #Hiringalert #Pharmajobs

 Greetings from Aurobindo Pharma Limited,  We are hiring SENIOR MANAGER / ASSISTANT GENERAL MANAGER in Quality Department for a Greenfield Project at #Kakinada Location.  

Interested candidates can scan to apply and to find out more .

Scientist-I / Scientist-II / Scientist-III - Regulatory Affairs-USMarket-OSD (R&D) | Aurobindo Pharma Limited

• Experience in Regulatory Affairs of US mkt. Review, compilation and submission of NDAs/ANDAs as per the FDA check list. Review, compilation and submission of Annual reports and post approval changes such as CBE, CBE 30 and PAS (Prior Approval supplements).
• Years of Experience 6-10 years
• Education Qualification for the position B.Pharma/M.Pharma

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Senior General Manager - Corporate QA (Sterile Assurance)

1. Harmonization of procedures and practices:
a. Draft / review / update Policies, Procedures related to Microbiology and Sterile Assurance.
b. Harmonize the Procedures related to Microbiology and Sterile Assurance across all units
2. Improving breadth and depth of Knowledge:
a. Identify and lead a network of Microbiology / Sterile Assurance Subject Matter Experts.
b. Act as a CQA Trainer for Microbiology and Sterile Assurance related Training programs.
3. Investigations and CAPA:
a. Act as CAPA coordinator for the CAPA related to Microbiology and Sterile Assurance.
b. Part of Investigations Team for Microbiology and Sterile related Investigations.
c. Act as Cross Functional Reviewer (CQA) for Microbiology and Sterile Assurance related changes, Non conformances, OOS etc, wherever applicable.
4. Act as Internal Auditor for Microbiology and Sterile Assurance area, wherever required.
5. Proactively assess risk, plan and execute audit deliverables. Work with sites to ensure their sterility assurance systems are properly prepared for external and internal compliance inspections.
6. Escalate Microbiology and Sterile Assurance related issues to Senior Management.

Years of Experience 22-25 years

Education Qualification for the position M.Pharm, M.Sc (Microbiology)

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