Quality (Plant) - Specialist, Validation

1 week ago

Toronto, Canada Voyant Beauty Full time

ROLES AND RESPONSIBILITIES
- Review CPP parameters, chemical and packaging batch sets for correctness associated with validation
- Prepare validation protocols and reports to support plant schedule and FDA/HC/Customer requirements for:

- IQ/OQ Qualification
- Process Validation
- Packaging Validation
- Cleaning Validation
- Purified Water Validation
- Computerized Systems
- Ensure all validation documentation is approved prior to execution
- Provide training on validation protocols and requirements
- Schedule and coordinate all validations activities by constant communication with affected departments and personnel
- Review laboratory, production and compounding results for compliance to validation protocol acceptance criteria, update the appropriate tracking and filing systems, and communicates results to Specification team for documentation updates.
- Prepare and maintain cleaning validation matrix and evaluate products to be validated via Cleaning Assessment
- Complete yearly summary reports for Purified, Potable and RO Water, Compressed Air and HVAC Systems
- Review and assess impact of changes to validation status, for cleaning, manufacturing and filling processes and equipment using appropriate change control procedures
- Update Master Validation Plans, Project Tracking Sheet, Equipment equivalency documents
- Work on special projects as assigned by the Validation Supervisor/Director, Quality
- Review of First Article Samples

Qualifications and Education Requirements
- University Degree in Science or Engineering
- Excellent written and oral English and strong technical writing skills
- Demonstrated knowledge of cleaning validation concepts
- Proven organizational, risk management, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast-paced environment
- Knowledge of FDA, HC and ICH validation guidelines
- Good knowledge & experience with Microsoft Word, Excel
- Must be able to work with a team and independently
- Minimum of 2 years experience in pharmaceutical or related industry

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