Senior Manager - Quality Assurance - Formulation Injectables

Senior Manager Quality Assurance – Formulation Injectables

Quality Assurance – Sterile Formulations

Reports To: Cluster Head – QA

Qualification: M.Sc / M.Pharm (Pharmaceutical Sciences / Quality Assurance / Microbiology or related)

Experience: 15–20 years of experience in Quality Assurance for sterile injectable formulation manufacturing.

Job Purpose:

To lead the Quality Assurance function for sterile injectable formulations by ensuring effective implementation of quality systems, compliance with regulatory requirements, and oversight of batch release, documentation, validation, and all related QA activities in a cGMP-compliant environment.

Key Responsibilities:

1. Quality Oversight & Team Leadership

• Lead QA functions across sterile injectable manufacturing lines.
• Allocate responsibilities and monitor performance of QA team members.
• Ensure adherence to cGMP, quality systems, and regulatory compliance.

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• Review and approve Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and analytical data.
• Perform batch disposition (release or reject) based on thorough quality review.
• Ensure control and lifecycle management of documents such as SOPs, BMRs, BPRs, STPs, and specifications.

3

• Develop, review, and upgrade QMS policy documents like Site Master File (SMF), Quality Manual, and Cross-Contamination Strategy.
• Monitor and review QMS activities such as:
• Change Controls
• Deviations
• CAPA (Corrective and Preventive Actions)
• OOS/OOT
• Market complaints and recalls
• APQR (Annual Product Quality Review)

4. Validation & Qualification

• Ensure execution and compliance of validation programs:
• Process validation
• Cleaning validation
• Equipment qualification (IQ, OQ, PQ)
• Facility and utility qualification
• Define IPQA procedures and oversee their effective execution.
• Review and approve validation protocols and reports.

5. Regulatory Compliance & Audit Readiness

• Ensure readiness for national and international regulatory inspections (USFDA, MHRA, EU-GMP, WHO).
• Prepare and review responses to inspection observations.
• Guide QA teams during internal and external audits.

6. Calibration, Maintenance & Environmental Monitoring

• Review schedules and compliance for calibration of instruments and preventive maintenance of equipment.
• Ensure compliance with environmental monitoring and microbial controls in sterile areas.

7.

• Review and approve documents generated electronically via platforms such as:
• DMS (Document Management System)
• QAMS (Quality Assurance Management System)
• LIMS (Laboratory Information Management System)
• NICHELON, CLEEN, or other enterprise QMS tools

8. Training & Continuous Improvement

• Identify training needs for QA staff and ensure implementation.
• Drive continual improvement initiatives in quality systems and compliance culture.

Key Skills & Competencies:

• Strong knowledge of aseptic/sterile injectable formulation processes
• Deep understanding of global regulatory guidelines (USFDA, EMA, WHO, etc.)
• Excellent documentation and data integrity compliance
• Leadership, team management, and decision-making abilities
• Proficient in use of electronic QMS tools

Preferred Candidate Profile:

• Successfully led QA functions for sterile injectable manufacturing facilities.
• Handled regulatory audits (USFDA, EU, MHRA, TGA, WHO).
• Experience in technology transfer and product lifecycle management.
• Ability to interface effectively with cross-functional teams (QC, Production, RA, Engineering).