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Team Lead/Associate Manager-Compliance Qa (Baddi)

12+ years
18-35 LPA
Baddi, India
10 June 11, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.