Apply on Kit Job: kitjob.in/job/4n6prc

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.

Apply on Kit Job: kitjob.in/job/4n6prc

📌 Manager, Quality Assurance (Kowdoor)
🏢 Amneal Pharmaceuticals
📍 Kowdoor