Senior Quality Assurance Manager

2 weeks ago

Bengaluru, Karnataka, India Apotex Full time
About Apotex Inc.

As a global health company, Apotex Inc. produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, we employ almost 7,200 people in manufacturing, R&D, and commercial operations. Our focus on vertical integration enables us to develop and sell generic, biosimilar, and specialty products. For more information, visit our website.

Job Summary

This role ensures the planning and monitoring of analytical activities, instrument calibration/qualification, investigations, and documentation in Quality Control at Apotex Research Pvt. Ltd. The successful candidate will report to the Head of Quality & Compliance and ensure operations in the Quality Control Laboratory follow established standard procedures.

Key Responsibilities:
  1. Report day-to-day activities to the Head of Quality & Compliance.
  2. Evaluate, review, approve, and ensure timely completion of changes in the QC department according to established change control procedures.
  3. Ensure smooth functioning of all laboratory instruments in coordination with service engineers.
  4. Responsible for reviewing and approving SOPs and directions for testing laboratory samples in QC.
  5. Perform work in accordance with established regulatory and compliance requirements.
  6. Conduct investigations for OOS/OOT results and ensure timely completion of laboratory analytical investigations.
  7. Manage Investigation, Deviation, CAPA, and Change Control Records and approval as 'Manager Approval'.
  8. Ensure a disciplined work environment and provide expertise to subordinates in proper performance of laboratory procedures.
  9. Interact with QA departments/Auditors during inspections or audits conducted by regulatory authorities.
  10. Assist the Quality group in various activities like data compilation for APQR, Training, Vendor development programs, Self-inspection, and External audit programs.
  11. Participate in handling Market complaints/Product recalls/Quality-related returns (if any) in coordination with the Quality group at Apotex affiliates and respond accordingly.
  12. Update knowledge with latest cGMP/GLP/Regulatory requirements and train departmental personnel accordingly.
  13. Lead performance conversations with employees, including monthly one-on-ones, to connect on performance, check progress toward achieving Objectives, offer support, remove barriers, communicate and revisit performance expectations to reinforce and encourage a high-performance culture and safe working environment for all employees.
  14. Create a culture that values trust and provides opportunities for employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance, and Passion.
  15. Utilize networks to attract and hire talent in a comprehensive, differentiated, and consistent manner essential to our continued growth; onboard new employees by providing a consistent experience reflecting the values and commitments made to candidates during the hiring process.
  16. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
  17. Take up any other work allotted by seniors and fulfill the same.
Requirements:
  1. Education: Minimum MSc/B Pharma or equivalent degree.
  2. Knowledge, Skills, and Abilities: Effective command over verbal and written communication with good interpersonal skills. Proficient in MS Office tools. Knowledge on preparation and review of various documents like SOPs, formats, protocols, reports, and analytical data. Knowledge on investigation and deviation report preparation. Having good command on troubleshooting instruments and analysis. Having well-versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities. Able to prioritize tasks and plan work activities effectively to meet timelines.
  3. Experience: Minimum 16 to 20+ years of experience in GMP regulated Pharmaceutical industry.

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