Job title: Cleaning Validation Coordinator
Contract:: 12 Months contract
Shift hours :: Shift Schedule: Fully Onsite - Monday – Friday 8:00 AM – 5:00 PM, 37.5 weekly hours.
Location: Whitchurch-Stouffville, ON L4A 0Y2
*Overtime is given after working beyond 38.75 ST hours.
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 Client site is required.
