Job Description – Assistant Manager, Quality Assurance

Department: Quality Assurance
Designation: Assistant Manager – QA
Industry: Pharmaceutical / API
Reporting To: Manager / Head – Quality Assurance

Job Purpose

To ensure that manufacturing, packaging, analytical, documentation, and quality-system activities comply with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, approved procedures, and the organization's Quality Management System (QMS).

Key Responsibilities

1. Quality Assurance & GMP Compliance

• Monitor and ensure compliance with cGMP, GLP, GDP, SOPs, specifications, and approved procedures.
• Perform IPQA activities during manufacturing and packing operations.
• Ensure line clearance, area clearance, sampling, and in-process checks are completed as per procedures.
• Monitor manufacturing and packaging activities for GMP compliance.
• Identify and report GMP/non-compliance issues and ensure appropriate corrective actions.

2. Batch Documentation Review

• Review and approve Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
• Review manufacturing, packaging, dispensing, and related QA documents.
• Ensure documentation is complete, accurate, traceable, and compliant with data-integrity requirements.
• Review analytical reports, certificates of analysis, logbooks, and relevant QC records.

3. Quality Management System

• Review and coordinate deviations, incidents, change controls, CAPA, OOS/OOT investigations, and effectiveness checks.
• Support root-cause investigations and ensure timely implementation and closure of CAPA.
• Monitor QMS actions and ensure compliance with defined timelines.
• Participate in quality-risk-management activities and continuous improvement initiatives.

4. Validation & Qualification

• Review/approve protocols and reports related to:
  • Process validation
  • Cleaning validation
  • Equipment qualification
  • HVAC qualification
  • Hold-time studies
  • Computerized systems validation, where applicable
• Ensure validation activities are performed according to approved protocols and regulatory requirements.

5. Audits & Regulatory Compliance

• Participate in internal audits, self-inspections, customer audits, and regulatory inspections.
• Support audit preparation and ensure availability of required documents and records.
• Track audit observations and coordinate timely corrective and preventive actions.
• Maintain the facility in an audit-ready condition.

6. Complaints, Recalls & Market Returns

• Support investigation and evaluation of customer/product complaints.
• Participate in product recall and market-return activities.
• Coordinate with Production, QC, Regulatory Affairs, and other departments for investigation and corrective actions.

7. Documentation & SOP Management

• Prepare, review, revise, and approve QA-related SOPs, formats, protocols, reports, and specifications.
• Ensure effective document control and archival of QA records.
• Ensure compliance with data-integrity principles such as ALCOA+.

8. APQR / Product Quality Review

• Coordinate and review Annual Product Quality Review (APQR/PQR) activities.
• Review trends related to batches, deviations, OOS/OOT, complaints, CAPA, stability, and process performance.
• Identify opportunities for quality and process improvement.

9. Training & Team Management

• Train QA personnel and other departments on GMP, SOPs, documentation, data integrity, and quality systems.
• Guide QA executives/officers in day-to-day activities.
• Plan and monitor departmental activities to meet quality and compliance objectives.

10. Cross-Functional Coordination

• Coordinate with Production, QC, Warehouse, Engineering, Regulatory Affairs, and other departments.
• Provide QA guidance for manufacturing, investigations, validation, and quality-system activities.
• Promote a strong quality culture across the organization.

Educational Qualification

• B.Pharm / M.Pharm
• B.Sc / M.Sc. in Chemistry, Microbiology, Biotechnology, or related discipline may be considered depending on the role.

Experience

• Typically 5–14 years of relevant experience in Pharmaceutical Quality Assurance, with the exact requirement depending on the organization and scope of the role.
• Experience in manufacturing/formulations, IPQA, QMS, audits, investigations, and regulatory compliance is preferred.

Required Skills

• Strong knowledge of cGMP and pharmaceutical QMS
• Deviation, CAPA, Change Control, OOS/OOT management
• BMR/BPR review
• IPQA and shop-floor compliance
• Audit and inspection handling
• Validation and qualification
• SOP/documentation management
• Data integrity and ALCOA+
• Root Cause Analysis and risk assessment
• Good communication, leadership, and problem-solving skills
• MS Office / documentation systems

Key Performance Indicators (KPIs)

• Timely closure of deviations, CAPAs, and change controls
• Compliance with GMP and internal SOPs
• Batch-document review turnaround time
• Audit/inspection readiness
• Reduction in recurring deviations and non-conformances
• Training compliance
• Timely completion of APQR and validation activities
• Data-integrity and documentation compliance