Quality Specialist, Validation/Qualification
QUALITY SPECIALIST JOB DESCRIPTION:
The Quality Specialist, Validation/ Qualification is responsible for all equipment and process validation and qualifications in all departments. The Quality Specialist, Validation/ Qualification ensures and monitors adherence to all facility SOPs relating to current Health Canada regulations, GMPs, and other applicable regulations. As the Quality Specialist, Validation/ Qualification you would be responsible for record maintenance of all validations and qualifications; as well as, ensuring that quality standards are met in the preparation and execution of these processes. They report to the Quality Assurance Manager.
- Review and approve selection, purchasing, commissioning, qualification and validation documentation of equipment, utilities, facility and processes with the focus on GMP compliance.
- Examples are but not limited to URS, DQ, FDS, FAT/SAT documents/commissioning documents, IQ, OQ, PQ, Validation plan, Risk assessment, validation summary report, SOPs.
- Maintain the equipment validation program and review all validation documents in the validation lifecycle to ensure compliance.
- Review and approve deviation/non-conformance/change control/CAPA (events) reports and records from validation/qualification perspective.
- Set up and maintain the validation periodic review program, including setting up the periodic review plan, performing periodic reviews and supporting revalidation works from QA’s perspective.
- Review software validation documents for Production process equipment, QC analytical instruments, spreadsheets, and other electronic systems.
- Support Engineering & Maintenance to set up a preventive maintenance and calibration program to ensure compliance with GMP requirements, and perform QA oversight on calibration and maintenance activities.
- Lead the inspection preparation and escort the inspections from the validation perspective.
- Support the setup and maintenance of other validation programs and activities including – process, method, cleaning, transportation, computer system validation.
- Design and implement cleaning procedures for new product and manufacturing equipment, lead enhancements and train employees on new/ revised processes and/or equipment.
- Ensures and enforces Good Documentation Practices on all applicable documents relating to GMPs.
- Complete all other tasks related to the position, as assigned by the Quality Assurance Manager.
- Bachelor of Science Degree (BSc) in Chemistry, Bio-Chemistry, Pharmacology, Pharmacy, Microbiology, Chemical Engineering, Medicine, Dentistry or Veterinary Medicine.
- 2 – 5 years of validation relevant work experience in the pharmaceutical or biologics manufacturing industry.
- Proven knowledge and experience in applying the risk-based approach throughout the validation lifecycle.
- Strong knowledge of GMP and QMS principles.
- In-depth understanding of validation requirements.
- Knowledge and experience with aseptic processing are desirable.
- Able to successfully obtain a clear criminal record check.
- Strong knowledge of MS Word, Excel and Outlook.
- Excellent analytical skills and above-average attention to detail.
- Excellent time management and prioritization skills.
- Oriented towards quality work and service.
- Excellent interpersonal skills, ability to work independently and in a team environment.
- Excellent English communication skills both written and verbal.
If you’re interesting in this Quality Specialist position, please send your resume and cover letter to firstname.lastname@example.org
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