Role & responsibilities

Job Title: Assistant Manager Audit Compliance (Corporate Quality Assurance)

Department: Corporate Quality Assurance (CQA) – Compliance

Location: Ahmedabad

Reporting To: Head – CQA Compliance

Team Size: 4

Experience: 11–15 Years

Qualification: M.Pharm / B.Pharm / M.Sc.

Job Purpose: To support and strengthen the Corporate Quality Assurance (CQA) Compliance function by ensuring GMP compliance, audit readiness, quality system harmonization, regulatory adherence, and effective implementation of corporate quality initiatives across manufacturing sites. The role will be responsible for conducting and managing internal audits, reviewing compliance systems, supporting regulatory inspections, and driving continuous quality improvement in line with global regulatory expectations.

Key Responsibilities

- Plan, schedule, and participate in Corporate Quality Audits, Self-Inspections, and Internal Audits across manufacturing sites.
- Review audit observations, compliance reports, CAPAs, and effectiveness checks to ensure timely closure.
- Monitor site compliance with cGMP, regulatory requirements, and corporate quality standards.
- Support manufacturing sites during regulatory inspections and review responses to regulatory observations.
- Review and harmonize SOPs, protocols, quality procedures, and quality system documents across manufacturing locations.
- Develop, review, and update Corporate Quality Guidelines, SOPs, and compliance procedures.
- Ensure implementation of evolving regulatory requirements and corporate quality expectations across manufacturing sites.
- Review quality documentation, audit reports, and Quality Technical Agreements (QTAs) for contract manufacturing and third-party sites.




- Participate in audits of third-party manufacturers and critical vendors supplying APIs, KSMs, Excipients, and Packaging Materials.
- Support vendor qualification activities and ongoing compliance monitoring.
- Review critical deviations, OOS/OOT investigations, customer complaints, and major quality events.
- Evaluate root cause analyses and CAPA effectiveness to ensure sustainable compliance.
- Drive continuous improvement through compliance reviews, trend analysis, and risk-based assessments.
- Track global regulatory updates and communicate applicable requirements to site Quality teams.
- Facilitate inspection readiness initiatives and support remediation projects across manufacturing sites.
- Compile, review, and analyze site quality metrics and monthly compliance data.
- Prepare and present Corporate Quality Assurance compliance reports, dashboards, and management updates.
- Monitor compliance trends and recommend corrective and preventive measures.
- Ensure adherence to Valuable Documentation Practices (GDP), Data Integrity requirements, and ALCOA+ principles.
- Review GxP records, reports, and documentation from a Data Integrity compliance perspective.
- Support investigations related to potential Data Integrity observations and ensure effective corrective actions.




- Coordinate departmental training activities through Learning Management Systems (e.g., QEdge TMS).
- Mentor and guide team members in achieving quality and compliance objectives.
- Promote a proactive quality culture and drive compliance excellence across the organization.
- Collaborate with cross-functional teams including QA, QC, Manufacturing, Regulatory Affairs, and Supply Chain to strengthen quality systems and regulatory compliance.

Technical Competencies:

- Strong knowledge of cGMP, GDP, Data Integrity, and Quality Management Systems.
- Expertise in Internal Audits, Regulatory Audits, and Compliance Management.
- Experience in CAPA, Deviations, Change Control, Risk Management, and Investigations.
- Knowledge of USFDA, MHRA, EMA, TGA, WHO, and other global regulatory requirements.
- Experience in Vendor Qualification and Third-Party Manufacturing Oversight.
- Strong understanding of sterile/injectable manufacturing compliance requirements.

Behavioural Competencies:

- Strong analytical and problem-solving skills.
- Excellent communication and stakeholder management abilities.
- Leadership and team management capability.
- High attention to detail and compliance focus.
- Ability to work cross-functionally and drive quality improvements.

Preferred Candidate Profile:

- 11–15 years of experience in Quality Assurance, Corporate Quality Assurance, Audit Compliance, or Regulatory Compliance within the pharmaceutical industry.
- Prior experience handling regulatory inspections and corporate quality audits.
- Exposure to sterile/injectable manufacturing facilities will be preferred.
- Experience working in USFDA-approved pharmaceutical companies.

📌 Assistant Manager Audit Compliance Corporate Quality Assurance (Ahmedabad)
🏢 Intas
📍 Ahmedabad