Executive - EMQ Batch Record Review

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. Responsible for timely compilation of batch release documents under guidance of Global External Manufacturing Quality.
4. Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in US and Canada market.
5. Escalate to QA Release team any critical non-conformances that may impact compliance of the batch.
6. Develops and maintains Quality Product Compliance files for the US & Canada market place based on current GMP Regulations.
7. Review of Third Party APQRs –ensuring raw data is complete, correct and reproducible.
8. Initiate the Change Controls in TrackWise, where no RA assessment required.
9. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
10. 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.
11. 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.
  • Experience into Sterile Product Manufacturuing is must and having exposure to OSD product manufatcurung would be an added advantage. 
  • Strong understanding of regulatory agencies ( Health Canada and USFDA ) requirments.