Manager, Quality Control, PL-APRL-QC AR
1 week ago
About Apotex Inc.
Apotex Inc. is a global health company based in Canada that specializes in producing affordable, high-quality medicines for patients worldwide. With a workforce of nearly 7,200 employees across the globe involved in manufacturing, R&D, and commercial operations, Apotex medications are available in over 75 countries. Through vertical integration, the Apotex group focuses on developing and selling generic, biosimilar, and specialty products.
Job Summary
The role involves overseeing and monitoring analytical activities, instrument calibration/qualification, investigations, and documentation in Quality Control at Apotex Research Pvt. Ltd.
Job Responsibilities
- **Report** to Head of Quality & Compliance on daily activities to Head, Quality Control.
- Ensure **operations** in Quality Control Laboratory adhere to established standard procedures.
- Identify **training** needs of departmental employees and address them.
- Support Manufacturing Operations during exhibit batches/commercial batches execution within set timelines.
- Review and approve changes in the QC department as per approved change control procedure.
- Monitor timely completion of commercial sample analysis.
- Maintain **proper functioning** of all laboratory instruments with service engineers' coordination.
- Review and approve SOP's and testing directions for laboratory samples in QC.
- Ensure compliance with established regulatory, compliance, **safety requirements**.
- Conduct investigations for OOS/OOT results, identify causes, and ensure timely completion of analytical investigations.
- Evaluate Investigations, Deviations, CAPA, and Change Control Records with 'Manager Approval'.
- Foster a disciplined work environment and provide expertise to colleagues in **laboratory procedures**.
- Collaborate with QA department/Auditor during inspections or regulatory audits.
- Assist Quality group in various activities like data compilation for APQR, Training, Vendor development, Self-inspection, and External audit program.
- Handle Market complaints/Product recalls/Quality-related returns (if any) in coordination with Quality group.
- Stay updated on the latest cGMP/GLP/Regulatory requirements and **train** departmental staff accordingly.
- Lead performance conversations with employees, support their progress, communicate performance expectations, and build trust-based relationships.
- Create a **culture** that values trust, fosters Employee development, and growth while demonstrating core Values – Collaboration, Courage, Perseverance, and Passion.
- Utilize networks to attract and hire talent in a consistent manner essential for continued growth, and provide a seamless onboarding experience for new employees.
- Ensure team adherence to compliance programs, company policies, and procedures.
- Complete any other assigned tasks from seniors.
Job Requirements
- Education Minimum MSc/B Pharma or equivalent degree.
- Knowledge, Skills, and Abilities: Effective verbal and written communication, strong interpersonal skills, proficiency in MS Office tools, preparation and review of various documents, investigation and deviation report preparation, troubleshooting on instruments, in-depth knowledge of regulatory guidelines and cGMP activities, **task prioritization**, effective planning of work activities to meet deadlines.
- Experience: Minimum 16 to 20+ years of experience in GMP regulated Pharmaceutical industry.
Apotex is dedicated to creating an inclusive, accessible work environment where every employee feels valued, respected, and supported. Accommodations for applicants with disabilities are available during the recruitment process. If you require an accommodation for an interview or testing, please inform us.
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