The GMP Quality Specialist (GMP and Validation) is responsible for building and maintaining a growing and integrated Quality Management System (“QMS”) that is compliant with European Good Manufacturing Practices (“GMP”) including ICH, EudraLex Volume 4, GUI-0001, GUI-0104 requirements from major regulatory bodies including but not limited to Health Canada and individual countries’ medicines agencies.
Responsible for equipment and process validation and qualifications in GMP related processing area. The GMP Quality Specialist ensures and monitors adherence to all facility SOPs relating to current Health Canada regulations, GMPs, and other applicable regulations. As the GMP Quality Specialist, you are responsible for supporting will lead the GMP certification including master site file creation, record maintenance of all validations and qualifications; as well as, ensuring that quality standards are met in the preparation and execution of these processes.
POSITION OVERVIEW Reporting to the Quality Control Manager, you are responsible for quality assurance (“QA”) oversight on GACP controls in cultivation, lead GMP certification, lead validation activities as well as creation of SOPs and operational record keeping for the company’s GMP operations including creation of the site master file for the site.
- Knowledge and understanding of GMP regulatory requirements as established by Health Canada’s Good Manufacturing Practices (GMP) Guidelines (GUI-0001), Health Canada’s Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API) (GUI-0104), the European Commission’s Eudralex Vol. 4 Good Manufacturing Practice Part II: Basic Requirements for Active Substances used as Starting Materials, and the European Medicines Agency ICH Topic Q7.
- Cross- functionally lead the EU-GMP certification process under guidance of the Quality Control Manager. This includes, but is not limited to:
- Master site file creation
- Design, implement and continuously improve SOPs as required
- Employee training
- Design, implement and continuously improve equipment and material procurement, commissioning, qualification and validation
- Design, implement and continuously improve facility, utility, sanitation and process qualifications and validations (including GMP, Good Agricultural and Collection Practices, Good Documentation Practices and Good Distribution Practices)
- Cross-functionally oversee EU-GMP operations on site for full compliance to associated regulations. This includes, but is not limited to:
- Document and record maintenance and review throughout lifecycle
- Initiate, justify and lead any CAPAs, deviation reports, change controls, non-conformance reports and records under guidance of Quality Control Manager
- Validation review program creation and maintenance
- Preventative maintenance and calibration program leadership
- GMP audit management
- Implement QA approved changes
- Complete all other tasks related to the position, as assigned by the Quality Control Manager
WHO ARE WE LOOKING FOR?
- Degree in Life Sciences or relevant major
- 2 – 5 years relevant work experience in a GMP environment
- Experience working in a GMP processing facility is required
- Experience establishing a GMP facility is a strong asset
- Experience validating facilities, equipment, utilities, service providers, processes, sanitation under GMP is required
- Must have a documented health exam and eye exam demonstrating clearance for working within a GMP environment prior to commencement of GMP activities (it is an asset to have successfully completed these exams prior to interviews)
- Proven knowledge and experience in applying the risk-based approach throughout the validation lifecycle
- Strong knowledge of EU- GMP and associate guidance and regulations (EU an asset) and
- Strong understanding of QMS principles (experience setting up GMP-compliant QMS systems is a strong asset)
- In-depth understanding of validation requirements in the regulation and guidance
- Direct interaction with inspectors from major regulatory authorities
- Knowledge and experience with GMP processing is desirable
- Excellent interpersonal skills, ability to work independently and in a team environment
- Working efficiently with the ability to be innovative and identify creative solutions
- High proficiency in MS Word/Excel and good writing skills
- Strong sense of pride in ownership of, and quality of work
- Keen eye for Attention to detail
- Fluency in Spanish is a strong asset
- A true team player