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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 5 months ago
3.0 - 7.0 years
3 - 6 Lacs
Udaipur, Bangalore Rural
Work from Office
Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA
Posted 5 months ago
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