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Quality Control Manager

2 months ago

Bengaluru, Karnataka, India Apotex Full time

About Apotex Inc.

Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs a diverse team of professionals in manufacturing, research and development, and commercial operations.

Job Summary

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

Key Responsibilities

  1. Report to the Head of Quality and Compliance regarding daily activities and ensure adherence to established standard procedures.
  2. Identify departmental employee training needs and provide support to fulfill them.
  3. Assess, review, and approve changes in the QC department as per established and approved change control procedures.
  4. Ensure timely completion of analysis of commercial samples and smooth functioning of laboratory instruments in coordination with service engineers.
  5. Review and approve SOPs and directions for testing laboratory samples in QC.
  6. Perform all work in accordance with established regulatory and compliance requirements.
  7. Conduct investigations for OOS/OOT results and ensure timely completion of laboratory analytical investigations.
  8. Evaluate investigation, deviation, CAPA, and change control records and approve as 'Manager Approval'.
  9. Ensure a disciplined work environment and provide expertise to subordinate colleagues in proper performance of laboratory procedures.
  10. Interact with QA departments and auditors during inspections or audits conducted by regulatory authorities.
  11. Assist the Quality group in various activities, including data compilation for APQR, training, vendor development programs, self-inspection, and external audit programs.
  12. Participate in handling market complaints, product recalls, and quality-related returns in coordination with the Quality group at Apotex affiliates and respond accordingly.
  13. Ensure updating knowledge on the latest cGMP/GLP/regulatory requirements and train departmental employees accordingly.
  14. Participate in and lead performance conversations with employees, including monthly one-on-ones, to connect on performance, check in on employee progress, offer support, and remove barriers.
  15. Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners, and direct leaders while continuously improving leadership capabilities.
  16. 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.
  17. Utilize networks to attract and hire talent in a comprehensive, differentiated, and consistent manner essential to our continued growth, then onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
  18. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
  19. Take up any other work allotted by seniors and fulfill the same.

Requirements

  1. Education: Minimum MSc/B Pharma or any 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, and thorough knowledge on cGMP activities.
  3. Experience: Minimum 16 to 20+ years of experience in GMP-regulated pharmaceutical industry.

At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.