- Responsible to review and approve validation protocols for Cleaning validation studies, which details sampling plans, the testing parameters, requirements and responsibilities as well as review and approve final validation reports for accuracy and completeness
- Facilitate communication with Plant Operations, QC Laboratory, Maintenance, Engineering, Supply Planning across the Teva Canada locations on the execution of the various ongoing approved protocols to ensure schedule and procedural adherence.
- Facilitate meetings with stakeholders to discuss validation issues and provide information and recommendations for solutions and corrective actions and determine any impact on the validation study as part of the investigation process and oversee implementation and verification of corrective actions related to cleaning validation.
- Responsible to review, coordinate and approve the site scheduled for Cleaning Validation.
- Liaise, engage, collaborate with internal and external customers/sites to provide expertise and guidance on Cleaning Validation issues as required.
- Participate in audits by Regulatory authorities – Health Canada, US-FDA etc. and Teva Global in support of Cleaning Validation as required and execute/support all remediation and/or follow-up activities as a result.
- Review all change controls (manufacturing and packaging masters) to ensure no impact to validation matrix. Ensure matrix is kept up-to-date and accurate.
- Perform other activities as required.
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Cleaning Validation Specialist - Whitchurch-Stouffville, Canada - Teva Pharmaceuticals
Description
The opportunity
Reporting to the Director, this position directly leads and coordinates the work activities and execution of the cleaning validation program and all cleaning validation activities for all three (3) Teva Canada locations in accordance with established schedules, timelines and priorities ensuring a high standard of performance and efficiency. This position is responsible for providing expertise and guidance to Teva Canada sites on Cleaning Validation issues/concerns and to ensure adherence to validation procedures.
How you'll spend your day
Your experience and qualifications
University degree in Science, Engineering or related discipline
Minimum three (3) years Cleaning Validation experience
Technical expertise working with Microsoft Word, Excel, PowerPoint, Adobe Reader, Outlook Applications, LIMS, Trackwise Harmony and Knowledge Tree
Working knowledge of GMP/GLP regulations and other Regulatory requirements for Canadian, US and EU markets, WHMIS, and Safety Precautions
Knowledge of Manufacturing and Packaging processes in a Pharmaceutical environment
Time management and organizational skills to multi-task and determine priorities
Provide a leadership style that encourages high quality work, team participation and personal development
The individual in this role will spend some time (approx. 10%) in a manufacturing, packaging and laboratory environment and will have exposure to auditory influences
Some travel to other Teva sites (10%) required
