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Quality Validation Coordinator
2 months ago
Apotex Inc. is a leading global pharmaceutical company that specializes in the development, manufacturing, and distribution of high-quality, affordable medicines. With a strong presence in over 75 countries, Apotex employs a diverse team of professionals in various fields, including research and development, manufacturing, and commercial operations.
Job SummaryThe Quality Validation Coordinator will play a critical role in ensuring the quality and integrity of Apotex's products. This position will be responsible for performing duties in several areas, including equipment performance qualification, sterilization validation, cleaning validation, and the preparation of validation packages for regulatory submissions.
Key Responsibilities- Author, coordinate, and execute performance qualification protocols for all applicable production equipment.
- Author, coordinate, and execute sterilization validation protocols for all applicable production equipment and process simulations.
- Author and summarize cleaning validation risk assessment reports.
- Author, coordinate, and execute cleaning validation protocols in accordance with FDA, HPFBI, EC, and ICH guidelines.
- Assess the impact of proposed changes to validated production equipment, processes, and cleaning procedures.
- Prepare sterilization process validation and other reports for regulatory submissions, including responses to deficiencies, comparability protocols, new submissions, and supplements.
- Operate and maintain equipment and instruments designated to Quality Validation & Engineering RH.
- Assist in calibration and calibrate equipment and instruments as required.
- Write SOPs or Change Control Forms in the area of expertise.
- Evaluate and execute requalification and revalidation when there is significant change in either product or its manufacturing process and for ongoing validation maintenance.
- Communicate with suppliers to obtain required technical information.
- Provide technical support in the area of expertise as required by other departments.
- Peer review of validation documentation for errors, omissions, comprehension, and compliance with cGMP and SOPs.
- Work in a safe manner, collaborating as a team member to achieve all outcomes.
- Demonstrate behaviors 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.
- Education: A Bachelor of Science degree in a related field or an engineering degree.
- Knowledge, Skills, and Abilities: Proficiency in written and verbal English communication, knowledge of Excel, Word, other Microsoft office programs, and validation software packages would be an asset.
- Experience: Minimum of three to five years in validation, with experience in sterilization validation, cleaning validation, equipment qualification, and regulatory submission (sterilization).
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.
