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Associate, Quality Assurance Specialist
2 months ago
Apotex Inc. is a global pharmaceutical company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs a diverse team of professionals in manufacturing, research and development, and commercial operations.
Job SummaryThis role is responsible for planning and executing cleaning validation activities in accordance with regulatory guidelines and company policies. The successful candidate will work closely with cross-functional teams to ensure compliance and quality standards are met.
Key Responsibilities- Liaise with key stakeholders to generate CV Product and Equipment Risk Assessment reports, evaluating new and/or changes to product formulations and manufacturing equipment.
- Develop and execute Cleaning Validation protocols/studies, and subsequent reports, ensuring sampling requirements and acceptance criteria represent worst-case conditions and meet global regulatory compliance standards.
- Coordinate cleaning validation event activities, including sampling, cleaning, and testing requests, with production/packaging teams as required.
- Execute cleaning validation/verification events, including LIMS project generation, sampling preparation, visual inspection, and result entry.
- Review lab results for compliance to validation protocol acceptance criteria, update tracking and filing systems, and communicate results for equipment release.
- Evaluate, maintain, and order sampling supplies as necessary.
- Recommend changes to equipment cleaning procedures and sampling methods to ensure successful completion of cleaning validation studies.
- Provide coaching and training to technicians and operators involved in cleaning validation activities.
- Develop and deliver presentations on validation topics to internal teams and external stakeholders.
- Initiate and recommend changes to Standard Operating Procedures (SOPs) and master documents related to cleaning validation.
- Perform impact assessments for proposed changes to production equipment and cleaning procedures on the validation program.
- Provide technical assistance to external suppliers and internal departments on validation-related matters.
- Communicate project status updates to management through tracking sheets and project management tools.
- Education: Bachelor's degree in Science or Engineering.
- Knowledge, Skills, and Abilities: Demonstrated knowledge of cleaning validation concepts, organizational and project management skills, excellent communication skills, and high level of familiarity with Microsoft Office and LIMS systems.
- Experience: Minimum of 2 years of experience in the pharmaceutical or related industry.
Apotex is committed to fostering an inclusive and accessible work environment, where all employees feel valued, respected, and supported. We offer accommodation for applicants with disabilities and strive to create a workplace that promotes diversity and inclusion.
