Lead Executive - External Manufacturing Quality

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 Customer Complaint Management and Annual Product Quality Review. Interact with internal groups involved in Third Party Operations (e.g., RA, New Product Launch, Supply Chain, Sales & Marketing and other Quality groups).

Job Responsibilities

1. Responsible for handling Customer Complaints for products manufactured by Third Parties according to the Customer Complaint process.
   • Manages the receipt of incoming customer complaints.
   • Triaging of all incoming complaints.
   • Logs complaint details into customer complaint system and sends out Acknowledgement Letter to complainants.
   • Notify the Third-Party manufacturer of incoming complaints.
   • Tracks investigation progress by Third Party manufacturer.
   • Review Third Party Investigation Report to ensure that complaint was satisfactorily investigated and adequate CAPA identified.
   • Close complaints and sends out Response Letter to complainants.
   • All non-critical complaints that are identified as Critical (during investigation outcome or new information) must be escalated to Global External Manufacturing Quality on same day.
   • All critical complaints with known problem type but not limited to (e.g., Leaking PFS, Red spot on SGC, Solubility & Precipitate).
2. Review the final APR using vendor’s APR and Apotex’ s APR and submit it to Manager in Canada for final approval.
3. Assists in the development of processes for Product Compliance File assessment and gap closure. Provides support to Regulatory Affairs & Corporate Quality on internal requests for information held at Third Party Manufacturers.
4. Supports in the development of SOPs to ensure efficient and compliant External Quality functions.
5. Coordinates a centralized documentation control system for External Quality. Coordinates the routing for review, issuance and archiving of External Quality controlled documents.
6. Updates and maintains the External Quality database for Third Party Manufacturers.
7. Works in a safe manner collaborating as a team member to achieve all outcomes.
8. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
9. 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.
10. All other 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 5-6 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.