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AM /Manager - Production (Hormonal / High Potent APIs) - Yadagirigutta

10 - 16 years

10 - 18 Lacs

Yadagirigutta

Posted:-1 days ago| Platform: Naukri logo

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Skills Required

Production Operations Production Management Production Supervising Manufacturing Management Production

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Supervise daily production operations in the hormone manufacturing block. Monitor batch execution as per approved schedules and ensure timely delivery. Maintain accurate documentation including BMRs, logbooks, and deviation records. Adhere strictly to cGMP, GDP, and EHS protocols in hormone manufacturing. Coordinate with QA, QC, Engineering, and SCM for smooth operations. Support process validation, scale-up, and equipment qualification activities. Ensure proper handling and disposal of hormone-related materials and wastes. Implement and monitor cleanroom protocols and environmental standards. Ensure compliance with regulatory requirements (USFDA, EU, WHO, etc.). Train and guide production operators and junior staff on SOPs, safety, and best practices. Maintain equipment readiness through coordination with maintenance teams. Participate in internal and external audits, and provide necessary production data. Monitor production KPIs and suggest improvements for operational efficiency. Preferred candidate profile Strong understanding of hormone/HPAPI production processes Working knowledge of cGMP, GDP, and regulatory standards Experience in handling regulated audits (USFDA, EU, WHO preferred) Effective communication and team supervision skills Familiarity with cleanroom operations and containment protocols

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