Job Responsibility
- Participate in designing, writing and implementing SOPs and documents in compliance with GMP standards, including but not limited to protocols for qualification and validation.
- Ensure that documentation, complaints, deviations, non-conformances, investigations, corrective and preventative actions, and change control are performed according to quality and regulatory requirements.
- Implement and execute inspection, testing, and evaluation methods to ensure that operations adhere to required quality standards.
- Perform or oversee internal quality audits; prepare site and staff for Health Canada and other regulatory inspections.
- Participate in external audits when they arise.
- Periodically verify the qualification and maintenance of premise and equipment.
- Follow the safety rules and housekeeping principles to ensure all working areas are clean and safe
- Other responsibilities as assigned.
Education & Experience
Minimum BSc (3-7 years related experience) or MSc (2-5 years). A science degree from a Canadian university or from an institution recognized as equivalent by a Canadian university or Canadian accreditation body, is a must.
Experience working in a GMP regulated environment.
Skills
- Experience working in a GMP regulated environment
- Excellent organizational and time management skills
- Proven ability to identify quality issues and proactively resolve issues in a team setting.
- Ability to work well in a collaborative environment or independently
- Organized
- Self-motivated
- Creative and innovative thinking
- Ability to use Microsoft office software is a must
Closing Date
Open until filled.
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