Key Responsibilities and Primary Duties:
- Assist in the preparation, execution, and reporting of cleaning validation studies.
- Coordinate/perform equipment swabbing and rinse sampling activities.
- Support the collection, review, and organization of cleaning validation data.
- Assist in evaluating cleaning validation results against established acceptance criteria.
- Support periodic review of cleaning validation programs.
- Prepare and revise protocols, reports, risk assessments, and related validation documentation.
- Ensure documentation complies with GMP, company procedures, and regulatory requirements.
- Support investigation activities related to cleaning validation deviations and excursions.
- Maintain validation files and ensure documentation is inspection-ready.
- Coordinate activities between QA, QC, Operations, Engineering, and MS&T.
- Schedule cleaning validation studies around manufacturing activities.
- Support risk assessments (FMEA, Risk Assessments, Gap Assessments) related to cleaning validation activities.
- Assist in identifying worst-case products and equipment locations.
- Support continuous improvement initiatives for cleaning procedures and validation practices.
- Help trend cleaning validation results and identify recurring issues.
- Maintain compliance with cGMP, Health Canada, FDA, EMA, and internal quality standards.
- Participate in investigations, CAPAs, and change controls as required.
- Other duties as required.
Position Requirements:
- Bachelor’s degree in Science, Engineering, Pharmacy or related discipline.
- One (1) to Two (2) + years of relevant experience, preferably in the pharmaceutical industry.
- Computer literate and proficient in: Microsoft Word, Excel, PowerPoint, Adobe Reader, Outlook Applications, LIMS, and Knowledge Tree, Track wise and Veeva.
- 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 is preferred.
- Time management and organizational skills to multi-task and determine priorities.
- Some travel to other Teva site is required.
“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”
