Sr. Exe / Asst. Manager - IRA Vaccine (ROW Market) Zydus Lifesciences Ltd, Ahmedabad

4.0 - 8.0 years

6 - 10 Lacs

ahmedabad

Work from Office

Job Responsibilities: Overall Responsibilities: 1. Compiling all the relevant information necessary to prepare best regulatory dossier (M1 to M5) for registration of a new vaccine or a license update in all concerned row countries including WHO Prequalification. 2. Developing and maintaining the Regulatory Dossier Module 1 to Module 5 keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions. 3. Participating and performing change control assessment (CCRs) of any necessary changes and implementation plan with a global view for the impacte...

Posted 3 weeks ago

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Assistant Manager & Deputy Manager Xapsol Xtramile People Solution

8.0 - 10.0 years

8 - 10 Lacs

Udaipur, Bengaluru

Work from Office

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Posted 3 months ago

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