Manager, Quality Control, PL-APRL-QC AR

Job Summary

To ensure planning and monitoring of analytical activities, Instrument Calibration / Qualification, Investigations and Documentation as per the procedure in Quality control at  Apotex Research Pvt. Ltd.

Job Responsibilities

1. Report to Head of Quality & Compliance regarding day to day activities to Head, Quality Control.
2. Ensure the operations in Quality Control Laboratory as per the established  standard procedure.
3. Identify the departmental employees training needs and to fulfil the same.
4. Provide support to Manufacturing Operations during the execution of exhibit batches / commercial batches within the stipulated time line.
5. Assess, review, approval and ensure the timely completion of the changes in QC department as per established & approved change control procedure.
6. Ensure timely completion of analysis of commercial samples.
7. Ensure smooth functioning of all laboratory instruments in co-ordination with service engineers.
8. Responsible for reviewing and approval SOP’s and directions for testing of laboratory samples in QC.
9. Perform all work in accordance with all established regulatory and compliance and safety requirements.
10. Conduct investigation for OOS / OOT results, and to identify assignable cause wherever applicable and to ensure timely completion of laboratory analytical investigations.
11. Evaluation of Investigation, Deviations, CAPA and Change Control Records and approval as ‘Manager Approval’.
12. Ensure a disciplined work environment and to provide expertise to subordinate \ colleagues in proper performance of laboratory procedures.
13. Interact with QA department / Auditor during inspections or any audit conducted by regulatory authorities.
14. Assist Quality group in various activities like data compilation for APQR, Training, Vendor development programme, Self-inspection and External audit programme.
15. Participate in handling of Market complaints / Product recalls / Quality related returns (if any) in co-ordination with Quality group at Apotex affiliates and responding the same if required.
16. Ensure to update (self) with latest cGMP / GLP / Regulatory requirements and to train the same to the departmental people.
17. Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
18. Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
19. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
20. Utilize your 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.
21. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
22. Take up any other work allotted by seniors and to fulfil the same.

Job Requirements

• Education
  • Minimum MSc /B Pharma or any equivalent degree.
• Knowledge, Skills and Abilities
  • Effective command over verbal and written communication with good interpersonnel skills.
  • Proficient in MS office tools.
  • Knowledge on preparation and review of various documents like SOPs, formats, protocols, reports and analytical data etc.
  • Knowledge on investigation and deviation report preparation.
  • Having good command on trouble shooting on instrument and analysis.
  • Having well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities.
  • Able to priortise the task, best in effective planning of work activities to meet the timelines.
• Experience
  • Minimum 16 to 20+ years of experience in GMP regulated Pharmaceutical industry.