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Cleaning Validation Specialist

3 months ago

WhitchurchStouffville, Canada Tevapharm Full time

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Cleaning Validation Specialist (12 Months Contract)

Date:  Jul 4, 2024

Location: 

Stouffville, Canada, Ontario, L4A 1H5

Job Id:  55827

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

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
  • 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.
     
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
 

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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