The Validation Specialist is responsible for all equipment and process validation and qualifications in all departments. The Validation Specialist ensures and monitors adherence to all facility SOPs relating to current Health Canada regulations, GMPs, and other applicable regulations. As the Validation Specialist, 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. The role will report to the Director, Compliance.
- 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.
- Perform and assist with qualification and validation of new and existing equipment, utilities, facility and processes with the focus on GMP compliance.
- Maintain the equipment validation program and review all validation documents in the validation lifecycle to ensure compliance.
- Perform risk assessment activities.
- 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 re validation works from QA’s perspective.
- Review software validation documents for Production process equipment, QC analytical instruments, spread sheets, 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 Director, Compliance.
- Bachelor of Science Degree (BSc) in Chemistry, Bio-Chemistry, Pharmacology, Pharmacy, Microbiology, Chemical Engineering, Medicine, Dentistry or Veterinary Medicine.
- 2 – 5 years validation relevant work experience in 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 is desirable.
- Able to successfully obtain 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 your experience and skill set aligns with the above please submit your resume to firstname.lastname@example.org with subject line ‘Validation Specialist’
We offer a welcoming and friendly space for BIPOC & LGBTQ+ applicants.
About The Valens Company
The Valens Company is a global leader in the end-to-end development and manufacturing of innovative, cannabinoid-based products. The Company is focused on being the partner of choice for leading Canadian and international cannabis brands by providing best-in-class, proprietary services including CO2, ethanol, hydrocarbon, solvent-less and terpene extraction, analytical testing, formulation and white-label product development and manufacturing. Valens is the largest third-party extraction Company in Canada with an annual capacity of 425,000 kg of dried cannabis and hemp biomass at our purpose-built facility in Kelowna, British Columbia which is in the process of becoming European Union (EU) Good Manufacturing Practices (GMP) compliant. The Valens Company currently offers a wide range of product formats, including tinctures, two-piece caps, soft gels, oral sprays and vape pens as well as beverages, concentrates, topicals, edibles, injectables, natural health products and has a strong pipeline of next-generation products in development for future release. Finally, the Company’s wholly-owned subsidiary Valens Labs is a Health Canada licensed ISO 17025 accredited cannabis testing lab providing sector-leading analytical services and has partnered with Thermo Fisher Scientific to develop a Centre of Excellence in Plant-Based Science. For more information, please visit http://thevalenscompany.com. The Company’s investor deck can be found specifically at http://thevalenscompany.com/investors/
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