This role is for a Production Associate at a leading Pharma API (Active Pharmaceutical Ingredient) Manufacturing company. The ideal candidate will have hands-on experience in API production and be responsible for executing batches while ensuring strict adherence to cGMP, safety, and quality standards.
Key Responsibilities
- Production Planning & Execution: Execute production batches according to plans and targeted commitments, ensuring compliance with cGMP and safety requirements.
- Quality & Compliance: Adhere to all process instructions as per the Batch Manufacturing Record, ensure good housekeeping, and maintain compliance with cGMP, Safety, Health & Environment (SHE) standards.
- Documentation: Perform all document entries online with legibility, review completed batch records for accuracy before handing over to QA, and ensure raw materials and APIs are properly labeled and stored.
- Reporting & Investigation: Immediately report deviations/incidents and support QA in investigations related to OOS (Out of Specification), Deviations, CAPA (Corrective and Preventive Actions), Incidents, and validations.
- Maintenance & Monitoring: Monitor and control the manufacturing environment, ensure preventive maintenance and calibrations are performed on schedule, and perform sanitization activities in the department.
- Inventory Management: Reconcile stocks at regular intervals to maintain accurate records.
Skills & Qualifications
- Experience in API production.
- Strong knowledge of cGMP, safety, and environmental regulations.
- Proficiency in handling Batch Manufacturing Records.
- The ability to work in a production environment and perform thorough documentation.
- B.Tech in Chemical Engineering, M.Sc in Chemistry, Diploma in Chemical, or B.Sc in Chemistry.
