Dy.Manager-Quality Assurance-Hormonal(API)@ Apichem Vangaplli MSN Group

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 handling. Conduct internal audits and ensure data integrity and compliance with ALCOA+ principles. Mentor, train, and guide the QA team to maintain high quality and compliance standards. Candidate Profile: B.Pharm / M.Pharm / M.Sc. Chemistry with 1215 years of experience in Hormonal API QA. Mandatory: Hands-on experience in handling QA for Hormonal APIs Should have independently faced audits and led a QA team. Strong understanding of regulatory expectations , quality systems, and documentation practices. Excellent leadership, communication, and cross-functional coordination skills

Posted 4 days ago

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Walk-in Interviews - Production(API) @ Indore MSN Group

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 1 week ago

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Walk-in Interviews - Production(API) @ Indore-Pithampur MSN Group

3.0 - 8.0 years

2 - 7 Lacs

Hyderabad

Work from Office

Posted 1 week ago

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