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Production Manager API
Natural Biogenex
posted 6d ago
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Job Description
- 10 to 15 years of experience in API production, with a strong focus on manufacturing operations, quality control, and compliance
- Qualification required- MSc (Organic Chemistry) / MTech (Chemical Technology) / BSc (Chemistry) Skills - We are seeking an experienced Production Manager to oversee and manage API production operations
- The ideal candidate will have in-depth knowledge of utility operations, shop floor management, batch planning, and execution
- Responsibilities include troubleshooting production issues, ensuring the production of quality products in line with GMP standards, and maintaining compliance with international regulatory bodies such as USFDA, WHO, and ICH-Q7A
- Key responsibilities include: Supervision of day-to-day shop floor operations and workforce management
- Ensuring batch planning, timely execution, and adherence to production timelines
- Troubleshooting production and operational issues efficiently
- Ensuring compliance with quality guidelines and regulatory standards (GMP, ICH-Q7A, USFDA)
- Experience in unit operations, including reactors (GLR, SSR, Hastelloy Autoclave), clean room operations, jet mills, AHU, and related utilities
- Handling steroidal and anticancer molecules, including operations and safety protocols
- Managing documentation according to SOP and GMP guidelines
- Leading customer and regulatory audits, including USFDA, TGA, and WHO Geneva
- Training and developing team members to enhance departmental performance
- Coordination for BOQ preparation and store management
- Overseeing finished goods handling and ensuring customer requirements are met
- If you possess expertise in production management and regulatory compliance and are looking to contribute to a leading API manufacturing unit, apply now to be part of our dynamic team
Employment Type: Full Time, Permanent
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