Specialist, Equipment Qualification

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

The Specialist, Equipment Qualification is responsible for planning, authoring, executing (Environmental mapping studies IQOQs and PQs) and maintaining qualification activities for production equipment, facilities, and utilities in accordance with the regulatory guidelines and applicable Apotex Inc. policies and procedures.

• Author Installation, Operation, and Performance qualification protocols and reports to ensure that equipment is correctly installed and operates as per the design and user’s specifications and is in compliance with the cGMP requirements.
• Document the critical parameters/instruments/attributes, and associated maintenance and calibration requirements and ensure verification in the protocol.
• Develop user-friendly tools and guidelines to achieve a consistent approach to Qualification, and support implementation plans to ensure compliance.
• Provide training on qualification topics to team members and potentially to customers and stakeholders outside the department or organization.
• Review, initiate and recommend changes to SODs and the VMP – Validation Master Plan for equipment and facilities qualification within Apotex Inc., specifications, and commissioning documentation.
• Coordinate the Equipment and Facility Qualification and Environmental Mapping activities as required.
• Provide troubleshooting assistance and suggest remedial and corrective actions for unacceptable validation or qualification results.
• Support projects and expansion efforts with respect to qualification of equipment, facilities, and utilities, and attend meetings as required.
• Work with Engineering to support authoring, review, or approval of FAT (Factory Acceptance Test) and SAT (Site Acceptance Tests) and participate in execution as required.
• Participate in investigations, audits, and improvement initiatives related to equipment, facility, and utilities’ qualification.
• Collaborate with Quality, Manufacturing, Engineering, Laboratories, Information Systems, Safety, Health & Environment, and other departments as required.
• Provide qualification technical assistance to outside suppliers and various departments and divisions within Apotex Inc.
• Ensure that procedures, work instructions, standard maintenance documents and plant maintenance data describing critical parameters or ranges determined in the qualification or environmental mapping reports are maintained in a qualified status and are audit-ready.
• Assist in implementing and monitoring progress against plans to achieve company goals and objectives within project timelines and budget.
• Re-qualify controlled spaces, and perform periodic reviews of the qualification status of designated equipment/facilities at defined periodic intervals.
• Review departmental systems and procedures on a periodic basis for compliance and suggest improvements.
• Coordinate completion of physical deliverables for the Engineering Change Management Program.
• Participate in monthly department meetings as required.
• Work in a safe manner, collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values:
  Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence to all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

• Education
  • Degree, diploma, or certificate in Engineering, Pharmaceutical Technology, a related science; or equivalent.
• Knowledge,
  
  Skills and Abilities
  • Demonstrated knowledge…