Executive, GBS-EMQ BatchRecRev-GBS-EMQ G

Job Summary

Responsible for execution of Quality Systems to ensure that Apotex meets its regulatory and GMP compliance obligations for Third Party manufactured products and products supplied by Apotex under contract to Third Party Organizations.  This includes Quality Systems to support New Product Launch and Submission batches. Interact with internal groups involved in Third Party Operations (e.g. RA, Supply Chain, Projects and other Quality groups as needed).

Job Responsibilities

1. Conduct the timely quality review of 3rd party full executed batch documents pertaining to Annual/New Product launch/Submission batches (where Apotex is the Marketing Authorization Holder) for accuracy and compliance to procedure to ensure that documents are in full compliance with cGMP, and regulatory standards.
2. Escalate to QA Release team any non-conformance reports (related deviations, OOS/OOT) associated with Annual/New Product Launch / Submission batches to ensure that incidents were satisfactorily investigated and to confirm that the batch to be released has not been adversely impacted and to escalate issues timely wherever appropriate.
3. Review vendor Certificate of Manufacture and Certification of Analysis as part of full review of execute batch record for Launch batches to confirm that product has been manufactured, packaged/labelled, tested and stored in accordance with vendor master production documents
4. Responsible to Coordinate / Follow up with third party manufacturing sites for responses to any non-conformance identified during batch review.
5. Responsible for timely compilation of batch release documents under guidance of Global External Manufacturing Quality.
6. Responsible for timely updation of batch release tracker associated with batch release activity.
7. Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in US and Canada market.
8. Escalate to QA Release team any critical non-conformances that may impact compliance of the batch.
9. Support in the development of SOPs to ensure efficient and compliant External Quality functions.
10. Coordinates a centralized documentation control system for External Quality. Coordinates the routing for review, issuance and archiving of External Quality controlled documents.
11. Works in a safe manner collaborating as a team member to achieve all outcomes.
12. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
13. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
14. All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor’s Degree in Science or a College Diploma in Pharmaceutical Technology, or a related field.
    
    

• Knowledge, Skills and Abilities
  • Strong knowledge of Global cGMPs (HC, FDA and EU) and the QA/QC systems associated with the manufacture of human drug products.
  • Detail-oriented, accurate and reliable.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Superior organizational skills, analytical thinking and inter-personal communication skills.
  • Ability to work independently or as part of a team.
  • Ability to build strong working relationships with Third Party partners.
  • Demonstrates personal leadership and accountability.
    
    
• Experience
  • At least 6-7 years of progressive Quality experience in QA or QA/QC roles.
  • Experience with Microsoft Computer Products (Word, Excel, Access, PowerPoint).
  • Experience with SAP and TrackWise is an asset.