* please note that this is a contract role*
Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!
We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.
We’d love to hear how you could contribute to the team!
Responsible for project planning, task assigning, prioritizing, and review and approval of qualification activities for GxP impacting Computer Systems in accordance with regulations and defined Apotex quality standards and policies
1. Ensure all areas of Quality Systems and e-Compliance are aligned with Global Quality objectives.
2. Ensure alignment of Apotex Global sites and affiliates towards Quality Systems regulatory requirements.
3. Act as compliance lead for Computer Systems Validation for Apotex Inc. and affiliate sites.
4. Perform assessments for Computer Systems Validation as required.
5. Conduct final review and approval of validation documents such as User Requirement Specifications, Validation Plans and Validation Summary Reports as per defined validation approach. This includes Change Controls.
6. Final review and approval of applicable Standard Operating Procedures.
7. Develop and maintain procedures/tools for validation and compliance with cGMP impacting computer systems to all regulations including 21CFR Part11.
8. Maintain procedures to regulate change implementation (Change Control Procedures) to ensure system compliance through its life cycle.
9. Perform final review and approval of vendor audits and internal audits (periodic review).
10. Implement and maintain compliance to validation program as per Global Validation Master Plan.
11. Apply values of Pride, Accountability, Integrity and Diligence to all duties and help to promote those values within the organization
12. Coordinate with GIS Project Manager and other team members to ensure timely completion of validation related tasks.
13. Lead departmental initiatives around Quality Systems.
14. Coach and mentor business users, project team and affiliate sites on Computer Systems Validation.
15. Demonstrate personal leadership attributes incorporating a commitment to on-going professional development and continuous learning.
16. Assist Global Director, QA Policy and Systems to ensure quality is built into systems and processes to ensure compliant decision-making and accountability from all areas of the business.
17. Act as main compliance lead in Global documentation remediation initiatives.
18. Build and maintain external relationships to enhance and improve Global quality (e.g. Vendors, Consulting groups, etc.)
19. Flexibility to work across all sites as required
20. Assist with hosting and conducting both internal and external audits as required
21. Demonstrate the PAID values (Pride, Accountability, Integrity, and Diligence) to maintain a sustainable quality culture.
22. Any other tasks as assigned.
• Minimum 5-7 years of validation experience in GMP regulated industry.
• College Diploma / Bachelor degree in a related discipline.
• Good understanding of GMP’s and GAMP standards including validation process.
• Knowledge of FDA’s 21CFR Part11 and other ER/ES regulations.
• Experience at writing/approving validation plans, IQ, OQ and PQ qualification protocols and reports for computerized systems.
• Experience in hosting/defending internal or external audits.
• Relevant experience on Client/Server applications; RDMS Database (Oracle SQL Server) applications; SAP system, LIMS, Empower, Equipment Control validation (PLC/SCADA), Network and Enterprise Content Management Systems.
• Demonstrated ability to coach others with a focus on changing behavior.
• Extensive Project Management experience.
• Strong customer service orientation.
• Knowledge of Software Testing Tools is preferred.
• Excellent communication/interpersonal skills.