QA AM HLL-IX

Job Description Assistant Manager, Quality Assurance


Job Purpose


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 514 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.