Qualification
l B.Sc / M.Sc Chemistry, Pharmacy, or related science field
l Minimum 5–10 years experience in API pharmaceutical manufacturing
l Strong knowledge of cGMP, ICH, US FDA,WHO GMP, and regulatory requirements
Job Purpose
To ensure implementation and maintenance of Quality Management System (QMS) and compliance with cGMP requirements in API manufacturing operations.
Key Responsibilities
l Ensure compliance with cGMP, SOPs, and regulatory guidelines.
l Review and approve:
l Batch Manufacturing Records (BMR)
l Batch Packing Records (BPR)
l SOPs
l Specifications
l Validation documents
l Change controls
l DMF Filling, RM Store, Production Work Flow.
l Deviations and CAPA
l Monitor documentation practices across departments.
l Conduct internal audits and self-inspections.
l Handle market complaints, investigations, and product recalls if required.
l Vendor Qualification
l Ensure calibration and preventive maintenance compliance.
l Review analytical reports and batch release documents.
l Train employees on GMP and data integrity requirements.
l Coordinate with regulatory authorities and customers during audits.
l Maintain QA records and ensure document control.
l Ready to work in rotational shifts as per plant and production requirements.
Skills Required
l Strong knowledge of cGMP and documentation practices
l Leadership and team management
l Investigation and root cause analysis
l Good communication and audit handling skills
Pay: Up to ₹800,000.00 per year
Benefits:
- Cell phone reimbursement
- Flexible schedule
- Health insurance
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund
Ability to commute/relocate:
- Boisar, Thane, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- How Many years of GMP QA experience ...?
- How Many years of experience in QMS handling..?
- Do you have any experience in Customer Handling..?
Education:
Experience:
- IN GMP QA: 10 years (Required)
Shift availability:
- Day Shift (Required)
- Night Shift (Required)
- Overnight Shift (Required)
Work Location: In person
