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.

Job Responsibilities

• 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.
• As required for each equipment/system protocol, 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. Support and implement plans to ensure that all Qualification work performed within Apotex Inc. is compliant to current regulatory requirements.
• Provide training on qualification topics as required to team members, and potentially to customers and stakeholders outside department or organization.
• Review, initiate and recommend changes (as applicable) to SOD’s, and 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.
• May provide troubleshooting assistance and suggest remedial and corrective actions in the case of 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, and Information Systems, Safety, Health & Environment, and other departments as required to achieve department objectives and business needs.
• 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 describe critical parameters or ranges determined in the qualification or environmental mapping reports are maintained in a qualified status and in an audit ready status.
• Assist in implementing and monitoring progress against plans to achieve the company goals and objective within project’s timelines and budget.
• Re-qualify controlled spaces, and perform periodic review on the qualification status of designated equipment/facilities at the defined periodic intervals.
• Review departmental systems and procedures on a periodic basis for compliance and suggest improvements as required.
• Coordinates completion of physical deliverables for the Engineering Change Management Program.
• Participate in monthly department meetings as required.
• Works 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 with 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.

Job Requirements

• Education
  • Degree, diploma, or certificate in Engineering, Pharmaceutical Technology, a related science; or equivalent.
• Knowledge, Skills and Abilities
  • Demonstrated knowledge of qualification concepts and GMP requirement.
  • High level of familiarity and proven experience with Excel, Word, Visio, PowerPoint, Access and TrackWise.
  • Able to manage multiple priorities in a fast-paced environment.
  • Proven organizational, problem solving, customer service, interpersonal and time management skills demonstrated by previous work experience to manage multiple priorities in a fast-paced environment.
  • Excellent communication skills.
• Experience
  • Minimum of 5 years experience in the pharmaceutical industry.