Description
JOB 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
QUALIFICATIONS
- 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.
