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:
Valuable 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 (India)
🏢 Basic Pharma Life Science
📍 India