Job Description

Key Responsibilities

Quality Management & Compliance

Establish, implement, and maintain the

Quality Management System (QMS)

Ensure compliance with

cGMP, GLP, GDP

, and applicable regulatory guidelines Ensure products meet

regulatory, safety, and quality standards

Regulatory & Audit Management

Handle

regulatory inspections

(USFDA, WHO, EU, MHRA, etc.) Prepare, review, and approve responses to

regulatory observations

Conduct and oversee

internal audits, vendor audits, and self-inspections

Documentation & Records

Review and approve: SOPs, protocols, and reports Batch Manufacturing Records (BMRs) Batch Packaging Records (BPRs) Validation documents and change controls Ensure proper

documentation control and data integrity

Deviation, CAPA & Change Management

Review and approve

deviations, OOS, OOT, and investigations

Ensure effective

CAPA implementation and follow-up

Evaluate and approve

change control proposals

Product Release & Stability

Final review and

batch release authorization

Oversight of

stability studies and product quality reviews (PQR/APQR)

Training & Team Leadership

Lead and mentor the QA team Ensure

training programs

for GMP, SOPs, and compliance Build a strong

quality culture

across departments

Cross-Functional Coordination

Coordinate with

Production, QC, Engineering, Regulatory Affairs, and Supply Chain

Support validation activities, technology transfer, and new product launches

Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹50,000.00 per month

Benefits:

Paid sick time Paid time off Provident Fund
Work Location: In person