Lead pharmaceutical quality assurance across sterile manufacturing operations, overseeing IPQA, GMP compliance, batch documentation, investigations, CAPA, change controls, audits, validation, quality systems, and regulatory inspection readiness. Manage QA and IPQA teams, collaborate with Production, QC, Engineering, Validation, and Regulatory Affairs, monitor quality metrics, and drive continuous improvement. The role requires 15–25 years of pharmaceutical QA experience, with strong sterile manufacturing and IPQA expertise.
This role is for one of Weekday’s clients
Salary range: Rs 1500000 - Rs 2700000 (ie INR 15 - 27 LPA)
Min Experience: 15+ years
Location: DAMAN, Vapi, Gujarat, India
JobType: full-time
We are seeking an experienced and highly capable Senior Manager – Quality Assurance (QA) with 15–25 years of experience in the pharmaceutical industry to lead and oversee quality assurance activities across manufacturing operations. The ideal candidate will have strong expertise in Sterile manufacturing and IPQA (In-Process Quality Assurance), with hands-on exposure to quality systems, regulatory compliance, manufacturing processes, and audit readiness.
The role will be responsible for ensuring that all manufacturing and quality operations comply with applicable GMP, regulatory, and internal quality standards. The candidate will work closely with Production, Quality Control, Engineering, Regulatory Affairs, and other cross-functional teams to maintain robust quality systems and drive continuous improvement.
Requirements
Key Responsibilities
- Lead and manage overall Quality Assurance activities for pharmaceutical manufacturing operations, with a strong focus on sterile products.
- Oversee IPQA activities across manufacturing areas, ensuring compliance with approved procedures, batch manufacturing records, SOPs, specifications, and GMP requirements.
- Provide QA oversight for sterile manufacturing operations, including aseptic processes, environmental monitoring, cleaning, sanitization, and contamination-control practices.
- Review and approve Batch Manufacturing Records, Batch Packaging Records, protocols, reports, SOPs, specifications, and other quality documents.
- Ensure timely investigation and closure of deviations, incidents, OOS/OOT results, CAPA, change controls, and market complaints.
- Establish and maintain effective quality systems in accordance with applicable GMP and regulatory requirements.
- Lead internal audits, customer audits, and regulatory inspections, ensuring appropriate preparation, response, and timely closure of observations.
- Monitor quality metrics and identify trends, risks, and opportunities for continuous improvement.
- Collaborate with Production, QC, Engineering, Validation, and Regulatory teams to resolve quality-related issues.
- Ensure effective implementation of CAPA, change management, risk assessment, and quality improvement initiatives.
- Mentor, develop, and manage QA and IPQA teams, promoting a strong culture of compliance, ownership, and quality excellence.
- Participate in process validation, cleaning validation, qualification, and other quality-related activities where required.
- Ensure appropriate training and qualification of QA personnel and manufacturing staff on GMP and quality procedures.
Must-Have Skills
- Sterile Manufacturing / Sterile Pharmaceutical Operations
- IPQA (In-Process Quality Assurance)
- Strong knowledge of GMP, Quality Management Systems, and regulatory compliance
- Experience in deviation management, CAPA, change control, and investigations
- Strong understanding of documentation and batch review processes
- Experience handling regulatory, customer, and internal audits
- Strong leadership and team management capabilities
- Excellent analytical, problem-solving, and decision-making skills
Good-to-Have Skills
- Experience in Injectables manufacturing and quality operations
- Exposure to aseptic processing and contamination-control strategies
- Experience with regulatory inspections and international GMP standards
- Knowledge of validation and qualification activities
- Experience with electronic Quality Management Systems (eQMS)
Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, or a related discipline.
- 15–25 years of relevant experience in Quality Assurance within the pharmaceutical industry.
- Strong experience in sterile manufacturing and IPQA is essential.
- Prior experience in a managerial or senior QA leadership position is preferred.
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