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Qualification

l B.Sc / M.Sc Chemistry, Pharmacy, or related science field

l Minimum 5–10 years experience in API pharmaceutical manufacturing

l Solid 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 Robust knowledge of cGMP and documentation practices

l Leadership and team management

l Investigation and root cause analysis

l Valuable communication and audit handling skills

Pay: Up to ₹800,000.00 per year

Perks:
Cell phone reimbursement
Flexible schedule
Health insurance
Leave encashment
Paid sick time
Paid time off
Provident Fund

Work Location: In person

Apply on Kit Job: kitjob.in/job/4m8gi3

📌 Qa Incharge Boisar
🏢 Chemco Innovative Chemie
📍 Boisar