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12.0 - 15.0 years
8 - 14 Lacs
Hyderabad
Work from Office
Role & responsibilities Lead the entire QA function for Hormonal API manufacturing, ensuring compliance with cGMP, ICH, USFDA, EUGMP and other regulatory guidelines. Develop, implement, and review SOPs , quality systems , change controls , deviations , CAPA , and risk assessments specific to hormonal APIs. Supervise batch release , review of BMRs/BPRs , and manage document control systems. Prepare and face regulatory inspections (USFDA, WHO, EUGMP, CDSCO, etc.) and client audits independently. Coordinate with QC, Production, Engineering, and Regulatory Affairs to ensure quality compliance across the plant. Monitor environmental conditions and containment protocols related to hormonal API han...
Posted 3 months ago
3.0 - 8.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Role & responsibilities Responsible for executing hormonal API production activities as per cGMP guidelines. Must have hands-on experience in operating isolators and handling high-potent compounds safely. Ensure compliance with SOPs, batch records, and maintain clean-room discipline. Should be familiar with equipment operation, in-process checks, and documentation practices
Posted 3 months ago
3.0 - 8.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Role & responsibilities Responsible for executing hormonal API production activities as per cGMP guidelines. Must have hands-on experience in operating isolators and handling high-potent compounds safely. Ensure compliance with SOPs, batch records, and maintain clean-room discipline. Should be familiar with equipment operation, in-process checks, and documentation practices
Posted 3 months ago
 
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