Manager, Quality Assurance

Description:

• Responsible for managing the Quality Management System (QMS), including deviations, OOS/OOAL investigations, CAPA, change control, and ensuring compliance with cGMP and regulatory requirements.
• Handle audits (regulatory, customer, internal), drive SOP/document control, training systems, and ensure continuous quality compliance across operations.
Support CMO, technology transfers, vendor qualification, and act as a quality interface for regulatory submissions and business requirements

Essential Functions:

• Ensure effective implementation and maintenance of the Quality Management System (QMS) in compliance with cGMP and regulatory requirements.
• Review and approve deviations, OOS/OOAL investigations, CAPA, and change controls to ensure timely and compliant closure.
• Oversee document control, SOP management, and training systems to maintain procedural compliance.
• Lead and manage regulatory, customer, and internal audits, ensuring audit readiness at all times.
• Drive quality risk management activities, including risk assessments and impact evaluations.
• Ensure data integrity (ALCOA+) across all quality systems and documentation.
• Support technology transfers, CMO activities, and validation programs from a QA perspective.
• Manage vendor qualification and ensure compliance of external service providers and CTLs.
• Monitor quality metrics and participate in Management Review Meetings (MRM) for continuous improvement.
Coordinate with cross-functional teams to ensure consistent quality compliance across operations

Additional Responsibilities: Ensure data integrity compliance (ALCOA+) across all quality systems and documentation.

• Monitor and review batch records, logbooks, and quality documents for accuracy and completeness.
• Drive continuous improvement initiatives to enhance quality systems and operational efficiency.
• Track quality metrics/KPIs and prepare reports for management review.
• Ensure readiness for regulatory inspections at all times (“audit-ready” state).
• Support implementation and compliance of electronic systems such as LIMS, QMS software, and track-wise systems.
• Coordinate with cross-functional teams (Production, QC, Engineering, Warehouse) for quality-related activities.
• Review and approve validation protocols and reports (process, cleaning, equipment, and analytical validation).
• Ensure compliance with environmental, health, and safety (EHS) standards related to QA activities.
• Mentor and train QA team members to build competency and ensure succession planning.

Education:

• Education: M.Sc. Chemistry / B.Pharma / M.Pharmacy

Experience: 10 to 15 Years

Specialized Knowledge:

• Exposure to regulatory audits (USFDA/MHRA/WHO)
• Experience in API manufacturing facilities.