Quality Control Manager Position

2 weeks ago


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

Apotex Inc. is a leading global health company that produces high-quality, affordable medicines for patients worldwide. With a strong presence in manufacturing, R&D, and commercial operations, Apotex employs nearly 7,200 people globally. The company's medicines are accessible in over 75 countries, and through vertical integration, Apotex focuses on developing and selling generic, biosimilar, and specialty products.

Job Summary

The Quality Control Manager will be responsible for planning and monitoring analytical activities, instrument calibration and qualification, investigations, and documentation according to established procedures in the Quality Control department at Apotex Research Pvt. Ltd.

Key Responsibilities:
  1. Report daily activities to the Head of Quality and Compliance.
  2. Ensure Quality Control Laboratory operations comply with established standard procedures.
  3. Identify departmental employees' training needs and fulfill them.
  4. Provide support to Manufacturing Operations during exhibit and commercial batch executions within specified timelines.
  5. Assess, review, and approve changes in the QC department according to established change control procedures.
  6. Ensure timely analysis of commercial samples.
  7. Coordinate smooth functioning of all laboratory instruments with service engineers.
  8. Review and approve SOPs and testing directions for laboratory samples.
  9. Perform work in accordance with regulatory and compliance requirements.
  10. Investigate OOS/OOT results, identify assignable causes, and complete laboratory analytical investigations.
  11. Evaluate investigation, deviation, CAPA, and change control records.
  12. Ensure a disciplined work environment and provide expertise to subordinate colleagues.
  13. Interact with QA departments during inspections and audits.
  14. Assist the Quality group in various activities, including data compilation, training, and vendor development.
  15. Handle market complaints, product recalls, and quality-related returns in coordination with the Quality group.
  16. Stay updated on cGMP/GLP/regulatory requirements and train departmental employees.

Apotex is committed to fostering an inclusive and accessible work environment where all employees feel valued, respected, and supported. We offer accommodation for applicants with disabilities as part of our recruitment process.



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