Quality Assurance

3 weeks ago

Halifax, Canada Solid State Pharma Full time

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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