Quality Assurance Specialist
At local level, conduct audits of the activities and projects as appropriate. Act as the lead auditor for complex/external audits.
Responsibilities:
Right Level of Quality & Strategy
- In their field of expertise, implement and improve the quality system.
- May release non GMP/GMP Product and materials (including investigational product).
- Is accountable for quality related decisions within or without project management (depending on seniority level)
- Can approve product related deviations and action plans.
- Complete the assigned CAPA, change control or any other assigned action in due time.
QMS & Documentation
- Write QMS documents.
- May approve SOPs in their area of expertise.
Community Building and Activation
- Ensure continuous improvement in the production process in relationship with local stakeholders.
- Build training modules and animate quality training sessions.
Audits & Inspections
- Conduct audits of studies, investigator sites, Contract Research Organizations and Contract Manufacturing Organizations, internal audits as appropriate.
- May host inspection.
- Auditing (Internal/External) – Perform and document audits. Determine corrective and preventive actions (CAPA) through negotiation with internal and external stakeholders.
Other Responsibilities
- Product Quality Review (PQR) – Collect data and perform trend analysis. Write annual PQR reports.
- Supplier/Vendor Qualification – Administrate the supplier qualification program. Collaborate with suppliers and vendors. Generate supplier questionnaire and collect data. Maintain records and database.
- Support for Qualification/Validation activities – Executing protocols in whole or in part. Contribute the protocol generation. Organize or conduct sampling as required.
- Environmental Monitoring (EM) program – Help organize and support EM scheduling and sampling. Collect and analyze data. Support aseptic qualification activities.
- Pest Control Program (PCP) – Monitor and collect PCP data. Coordinate activities with PCP service provider.
- Deviation Investigation – Investigate deviations, determine root cause, and document results. Determine and/or complete CAPA as required. Collect and analyze deviation trend data.
- CAPA/Change Control – Complete CAPA and administrate change control process as assigned.
- Training – conduct or assist in training activities within the relevant area of expertise.
Other duties as assigned.
Competencies:
- Drive Ambition & Accountabilities
- Influence Others
- Collaborate with Empathy
- Engage & Develop
- Shape Solutions out of Complexity
- Client Focus
Qualifications
- Post-secondary degree/diploma in biological sciences or related field preferred.
- Post-secondary degree/diploma in Quality Assurance/Control ideal.
- 3 years in a Quality Assurance role in which you were involved in the development and administration of quality assurance systems.
- Previous experience in pharmaceutical or similar industry.
- Previous experience within a GXP environment.
Disclosures:
- This requisition is for a current opening at our Guelph, ON facility
- Targeted compensation range is between $65-75k annual salary but may vary dependent upon education, skills and experience
Your profile :
Qualifications
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Post-secondary degree/diploma in biological sciences or related field preferred.
-
Post-secondary degree/diploma in Quality Assurance/Control ideal.
-
3 years in a Quality Assurance role in which you were involved in the development and administration of quality assurance systems.
-
Previous experience in pharmaceutical or similar industry.
-
Previous experience within a GXP environment.
