Description:
- Coordinate and execute the validation program to ensure the facility and all equipment, processes and systems are in a validated state of control, by maintaining Validation Master Plans, creating/compiling and/or reviewing validation packages, providing technical expertise and information resources to other departments and ensuring compliance to Regulatory and Corporate requirements.
- Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies, Health Canada, and PIC/S requirements.
- Utilize the Trackwise system for Change Control Management practices
- Create validation packages for systems, processes, test methods, and equipment to demonstrate a validated state of control.
- Write protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages.
- Coordinate validation and IQ/OQ/PQ activities with Production, Engineering, Quality Control Laboratories and outside contractors providing leadership, training and guidance.
- Monitor and support the execution of the protocols through training, facilitating and problem-solving activities.
- Provide guidance and assistance on validation formats, requirements and procedures as a team member on various validation projects.
- Support validation training for team members and provide resource information as a technical expert.
- Review completed validation packages for compliance with validation requirements.
- Manage the validation status of the facility and ensure change control requirements are captured, and support tracking all validation efforts via schedules & status logs for the facility VMP.
- Contribute / participate in facility Quality review meetings.
- Participate as the Validation SME during Regulatory and Corporate compliance inspections.
- Support the Baxter Quality System Improvement Plan (QSIP) by ensuring that quarterly Quality Quotient assessments are completed and opportunities are identified and action plans created.
Education Level
Required:
- University Degree, Bachelor of Science
Major Subjects / Specialties
Required:
- Science (Chemistry, Microbiology, Pharmacy, Engineering)
Preferred:
- Experience working with pharmaceutical liquids processing systems
Type of Experience
Required:
- Previous experiences in GMP environment
- Knowledge of GMP, ISO and Regulatory standards
- Excellent written & oral communication skills required for writing commissioning & validation test plans, and final reports
Preferred:
- Experience with liquid processing equipment is an asset.
- Knowledge of Corporate Quality requirements