Role
Supervise and optimize the manufacturing processes for Active Pharmaceutical Ingredients (API), ensuring quality, efficiency, and compliance with regulatory standards. Drive operational excellence and support scale-up activities in a dynamic production environment.
Key Responsibilities:
- Manage end-to-end API production activities, from raw material handling to final output.
- Ensure strict adherence to cGMP, EHS, and regulatory norms (like ICH, CDSCO).
- Collaborate with R&D, QA/QC, and engineering teams for tech transfers and process improvements.
- Monitor yield, batch records, equipment performance, and documentation accuracy.
- Train and guide staff on SOPs, safety practices, and production protocols.
Qualifications:
- Bachelor's/Master's in Pharmacy, Chemical Engineering, or related field.
- 5+ years of hands-on experience in API manufacturing.
- Proficiency in process control, instrumentation, and documentation systems.
- Strong leadership, analytical, and troubleshooting skills.
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