Production & Operations
- Execute and supervise manufacturing activities as per approved BMRs/BPRs.
- Ensure strict adherence to USFDA, cGMP, WHO-GMP, and Schedule-M guidelines.
- Monitor critical process parameters during manufacturing.
- Ensure proper line clearance, equipment cleaning, and changeover activities.
- Coordinate with QA, QC, Engineering, and Warehouse departments.

Compliance & Documentation
- Review and maintain Batch Manufacturing Records (BMRs) and logbooks.
- Ensure data integrity (ALCOA+) principles are followed.
- Initiate and support deviations, CAPA, change controls, and investigations.
- Ensure SOP compliance and participate in SOP preparation and revision.
- Maintain GDP (Positive Documentation Practices).

Regulatory & Audit Support
- Support USFDA, MHRA, WHO, and customer audits.
- Respond to audit observations related to production activities.
- Ensure implementation of corrective and preventive actions.

Equipment & Validation
- Ensure proper operation and calibration status of equipment.
- Support process validation, cleaning validation,



and equipment qualification.
- Identify opportunities for process improvement and efficiency.

Safety & Training
- Ensure compliance with EHS and safety procedures.
- Train production staff on SOPs, GMP, and safety practices.
- Promote a culture of quality, compliance, and continuous improvement.

Educational Qualification
- B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry):
- FDA / GMP certification preferred

Key Skills & Competencies
- Strong knowledge of USFDA & cGMP regulations:
- Expertise in BMR handling and GMP documentation:
- Understanding of data integrity & audit readiness:
- Good analytical, communication, and problem-solving skills
- Team handling and cross-functional coordination

Compliance Requirements
- Must strictly follow USFDA, cGMP, SOPs, and company quality policies:
- Zero tolerance for data manipulation or GMP violations

Job Types: Full-time, Permanent

Pay: ₹9,447.01 - ₹38,625.25 per m

📌 Chemist - Fda Approved (Ankleshwar)
🏢 Basic Pharma Life Science
📍 Ankleshwar