Cleaning Validation Associate
2 weeks ago
Apotex Inc. is a global pharmaceutical company that specializes in the development, manufacturing, and distribution of high-quality generic and biosimilar 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 Cleaning Validation Associate will play a crucial role in ensuring the quality and integrity of Apotex's products by planning and executing cleaning validation activities in accordance with regulatory guidelines and company policies.
Key Responsibilities- Liaise with cross-functional teams to generate Cleaning Validation Product and Equipment Risk Assessment reports, evaluating new and/or changes to product formulations and manufacturing equipment to determine if Cleaning Validation Protocol studies are required.
- 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 (FDA, HPFBI, EC, and ICH).
- Coordinate cleaning validation event activities, including sampling, cleaning, and testing requests, with production/packaging teams as needed.
- Execute cleaning validation/verification events, including:
- LIMS project generation and sampling preparation
- Visual inspection and sampling of equipment
- Delivery of samples to the laboratory
- Completion of LIMS and/or visual inspection form result entry and electronic filing of completed results
- Review lab results for compliance to validation protocol acceptance criteria, update tracking and filing systems, communicate results for equipment release, and summarize data for validation reports.
- Evaluate, maintain, and order sampling supplies as needed.
- Recommend changes to equipment cleaning procedures and sampling methods to ensure successful completion of cleaning validation studies.
- Provide coaching to technicians and operators involved in cleaning validation activities.
- Present validation topics to the validation team and other departments as required.
- Initiate and recommend changes to Standard Operating Documents (SODs) and master documents related to cleaning validation.
- Perform impact assessments for proposed changes to production equipment and cleaning procedures on the validation program using change control procedures.
- Provide technical assistance related to validation to outside suppliers and various departments and divisions within Apotex.
- Communicate project status updates to management through tracking sheets (Excel or MS Project).
- Education:
- Bachelor's degree in Science or Engineering
- Knowledge, Skills, and Abilities:
- Demonstrated knowledge of cleaning validation concepts
- Proven organizational, risk management, problem-solving, and project and time management skills
- Excellent English oral and written communication skills
- Strong technical writing skills
- High level of familiarity with Microsoft Office (Excel, Word)
- LIMS experience is an asset
- Experience:
- Minimum of 2 years of experience in the pharmaceutical or related industry
At Apotex, we are committed to fostering an inclusive and accessible work environment where all employees feel valued, respected, and supported.
We offer accommodation for applicants with disabilities as part of our recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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