Apotex Inc. QA Validation Supervisor in Richmond Hill, Ontario

About Apotex:

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 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!

Job Summary:

Responsible for managing and ensuring the compliance of projects related to Process Validation (including Sterile/Aseptic Process Validation), Cleaning Validation and Equipment and Facility Qualifications. Accountable for communicating status of these validation projects to the management group. Responsible for the review and approval of proposed validation documentation and strategies which ensure the validation program remains compliant with the TPD, FDA, EU, company SOPs and other regulatory guidelines. Responsible for providing guidance and acting as a resource with knowledge pertaining to the regulatory and Validation requirements for various departments.

Job Responsibilities:

  1. Defend the validation program during regulatory audits (act as primary point of contact) and interact with government agencies and professional colleagues to ensure company compliance to all regulatory requirements for validation.

  2. Supervise the preparation, execution and maintenance of validation documentation, Submission Packages and Comparability Protocols for Sterile/Cleaning Validation, including but not limited to:

  • Aseptic Process Simulations (media fills)

  • Aseptic operator qualification

  • Airflow Visualization studies

  • Thermal (moist / dry Heat) and gaseous (VHP / ETO) validation

  • Irradiation (gamma / e-beam) of primary packaging components

  • Container closure integrity

  • Sterilizing filter validation

  • viii. Equipment cleaning validation and routine monitoring

  • ix. Equipment Qualification for Sterile Lines

  1. Provide Quality guidance, review and approval of validation documents and change controls (for sterile and non-sterile lines), including:
  • Maintenance & Validation of facility, utility systems, and equipment

  • Manufacturing process validation

  • Critical instrument (include HEPA filter) certification and calibration

  1. Provide Quality guidance / assessment to ensure the maintenance of and changes to the validated systems, equipment and processes are managed in accordance with current corporate and regulatory requirements.

  2. Assist in the development, implementation and training for Standard Operating Procedures, Technical Manuals and Quality Policies relating to the Validation Services department.

  3. Ensure that all validation activities are coordinated appropriately with other departments to meet project timelines.

  4. Act as a member of teams / committees such as new product launch, change control board, etc. to provide guidance related to validation regulations/guidelines. Provide support to all other departments including Quality Assurance, R&D, Production, Engineering departments with respect to technical and quality/validation requirements.

  5. Ensure that all work is performed in full compliance with cGMP's, SOP's and established safety standards. Review validation strategies and associated documentation against the requirements of the Validation Master Plan to ensure that compliance and business needs are achieved.

  6. Support internal validation compliance requirements including protocol and report review and change control review.

  7. Act as a designate for the department Manager, reviewing and approving protocols, reports, change control records as a QA approver.

  8. Act as a lead investigator or Validation subject matter expect (SME) for QMS investigation records, making decisions and solving problems independently. Act as a QA SME for review/approval of proposed remedial and corrective actions related to deviations/investigations/excursions due to out of trend/out of specification validation/qualification data, as required. Ensure that any proposed CAPA are appropriately assessed for validation impact.

  9. Act as a QA Responsible for Engineering / Facility Change Controls. Perform technical assessments to determine impact of changes to the Validation Status, using the appropriate change control procedures and act as Validation and/or QA approver as required.

  10. Independently participate in the design, review, and approval of new Production equipment installations and processes.

  11. Recruit, train, develop and manage effectively the ongoing performance of direct reports, which includes, but is not limited to:

  • Author and independently conduct performance reviews with direct reports. Independently conduct performance improvement and development meetings with direct reports

  • Ensuring Job Descriptions are reviewed, signed and sent to Employee Services annually.

  • Review / update employee development plans and ensure that all employees are properly trained and qualified to execute their duties.

  • Provide coaching, feedback and recognition.

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

  2. Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).

  3. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence.

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

  5. All other duties as assigned.

Job Requirements:

  • Minimum three years supervisory experience in Validation, Quality, Product Development, Technical Services, Engineering or Production in the pharmaceutical industry.

  • Minimum B.Sc. (in related field) degree or equivalent experience in a sterile manufacturing facility (minimum 10 years sterile validation experience).

  • Experience in a sterile liquid dosage manufacturing environment, with a strong understanding of TPD, FDA, EU and other applicable regulatory guidelines related to Validation.

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

  • Knowledgeable user of SAP and TrackWise systems.

  • Ability to analyze systems and processes and recommend process improvement.

  • Excellent problem solving and troubleshooting abilities.

  • Excellent oral and written communications.

  • Strong interpersonal skills.

  • Demonstrated ability to work effectively as a team member with employees at all levels of the organization.

  • Ability to work independently with minimal supervision.

  • Strong customer service orientation.

  • Working knowledge in the use of Microsoft office tools or similar software.

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: 2016-4893

Job Type: Full Time

Job Industry (Choose up to 3 industries): Pharmaceutical

Career Level: Experienced