Team Lead / Associate Manager – Compliance QA (Contract Manufacturing)
Department: Quality Assurance – Contract Manufacturing
Location: Baddi
Job Type: Full-Time
Minimum Experience: 12+ Years
Experience Level
12+ years of experience in Pharmaceutical Quality Assurance
Experience in:
Contract Manufacturing Quality
Compliance QA
GMP Audits
Quality Systems
Regulatory Compliance
Team Lead / Associate Manager Level
Salary
Estimated market salary: ₹18–35 LPA CTC, with candidates from reputed pharma companies and strong audit/compliance backgrounds potentially earning ₹35–45 LPA.
Role Summary
The Team Lead / Associate Manager – Compliance QA will oversee quality compliance activities across contract manufacturing locations (CMLs), vendors, and external laboratories. The role focuses on GMP compliance, audits, investigations, CAPA management, quality systems oversight, and risk mitigation across pharmaceutical, cosmetic, nutraceutical, and food product manufacturing operations.
Key Responsibilities
Compliance Audits
Conduct external GMP and compliance audits at contract manufacturing sites.
Audit vendors and external laboratories.
Assess compliance against regulatory requirements, SOPs, and company quality standards.
Prepare audit reports and track closure of observations.
Contract Manufacturing Quality Oversight
Regularly visit contract manufacturing locations.
Monitor manufacturing compliance and quality systems.
Identify and mitigate quality and compliance risks.
Ensure adherence to approved manufacturing processes.
Investigation Management
Lead investigations related to:
Product failures
Market complaints
Deviations
Non-conformances
Out of Specification (OOS) results
Perform root cause analysis and recommend corrective actions.
CAPA Management
Review and approve CAPAs.
Monitor CAPA implementation and effectiveness.
Ensure timely closure of quality observations.
Escalate critical compliance issues to management.
Quality Management Systems (QMS)
Ensure effective implementation of:
Change Control
Deviation Management
OOS Management
Market Complaints
Training Systems
CAPA Programs
Support continuous improvement of quality systems.
Batch Record Review
Review Batch Manufacturing Records (BMR).
Review Batch Packing Records (BPR).
Verify documentation completeness and compliance.
Cross-Functional Coordination
Collaborate with:
Contract Manufacturing Locations (CMLs)
Vendors
External Laboratories
R&D
Production
Regulatory Affairs
Support quality and compliance initiatives across functions.
Required Technical Expertise
Manufacturing Knowledge
Hands-on shop-floor experience in:
Solid Oral Dosage Forms (OSD)
Semisolid Formulations
Liquid Dosage Forms
Powder Formulations
Cosmetics
Nutraceuticals
Food Products
Quality & Compliance
GMP
cGMP
Regulatory Compliance
Quality Audits
Risk Assessment
Investigation Management
CAPA
QMS
Preferred Qualifications
ISO Lead Auditor / Certified Auditor (preferred)
Experience handling third-party manufacturing audits
Exposure to multi-category products (Pharma, Cosmetics, Nutraceuticals, Food)
Key Skills
GMP Auditing
Compliance Management
Root Cause Analysis
CAPA Management
Change Control
Deviation Investigation
OOS Investigation
Vendor Qualification
Contract Manufacturing Oversight
Documentation Review
Stakeholder Management
Travel Requirement
Extensive travel required.
Frequent visits to contract manufacturing sites, vendors, and laboratories.
Ideal Candidate
A senior Quality Assurance professional with extensive shop-floor exposure, strong GMP compliance expertise, and proven experience managing audits, investigations, CAPA programs, and quality systems across pharmaceutical and contract manufacturing environments.
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