Apotex Inc. Equipment & Facility Qualification Specialist in Etobicoke, Ontario

Equipment & Facility Qualification Specialist

Job Summary:

  • The Equipment and Facility Qualification department is responsible for the following programs:
  1. Equipment & Facility Qualification: This program includes authoring, executing, review and approval of risk-based Installation, Operation, and Performance Qualification protocols, and review and approval of Site or Factory Acceptance Testing (SAT/FAT), other commissioning documentation and functional specifications to ensure that equipment or facilities, directly or indirectly affecting GMP areas at Apotex Inc., are correctly installed and operate according to the design and user’s specifications, and are in compliance with cGMP requirements.
  • This program additionally includes the procedural foundation for creating risk-based criticality assessments, periodic re-evaluation of the qualification status of equipment and facilities, and support for quality investigations and corrective and preventative actions (CAPA).
  1. Environmental Mapping Program for Controlled Spaces: This program oversees the authoring, executing, review and approval of Installation, Operation, and Performance Qualification protocols supporting the temperature and humidity (if required) mapping of controlled spaces at Apotex Inc.
  • This program additionally includes procedures for periodic requalification of such spaces including seasonal considerations, an in-house calibration program for all utilized mapping instrumentation, and support for quality investigations and corrective and preventative actions (CAPA).
  1. Equipment and Facility (Engineering) Change Control Program: This program assesses the impact of equipment or facility changes, changes to the Plant Maintenance Data system or the introduction of new equipment or systems, directly or indirectly affecting GMP areas at Apotex Inc., and recommends action deliverables, such as requalification, as required for their implementation into operation.
  • The Equipment and Facility Qualification Specialist 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.

  • Identify the critical parameters/instruments in these protocols and create proper tests to challenge the functionality of each parameter.

  • Identify maintenance and calibration requirements for the critical items and document these requirements in the protocols to make sure that it will be established and verified.

  • 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 by collaborating with all Subject Matter Experts (SMEs), customers and stakeholders.

  • Provide training on qualification topics as required to team members, and potentially to customers and stakeholders outside department or organization.

  • Collaborate with other departments as required to achieve department objectives and business needs.

  • 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.

  • Work closely with Quality, Manufacturing, Engineering, Laboratories, and Information Systems, Safety, Health & Environment groups to ensure that the Qualification team is involved as early as possible with new equipment acquisitions or projects within these areas so that appropriate qualification protocols are developed.

  • 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 re-evaluate 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.

  • Participate in monthly department meetings as required.

  • Works as a member of a team to achieve all outcomes.

  • Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.

  • Performs all work in accordance with all established regulatory and compliance and safety requirements.

  • All other duties as assigned.

Job Requirements:

  • Minimum 5 years related experience in the pharmaceutical industry.

  • Bachelor degree in Engineering or Science in a related discipline.

  • Demonstrated knowledge of qualification concepts and GMP requirement.

  • High level of familiarity with Excel, Word, Access, Visio, Power point and TrackWise applications required.

  • Proven organizational, problem solving, project and time management skills.

  • Able to manage multiple priorities in a fast paced environment.

  • Excellent communication skills.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

System ID: 2016-4917

Job Type: Full Time

Job Industry (Choose up to 3 industries): Pharmaceutical

Career Level: Experienced