About this role
We’re hiring a Quality Assurance Specialist for our client, a Global Pharmaceutical company, to join their team. This is a 6-month contract opportunity
- This role will act as a diversified technical person who works within the Quality Systems to support B90 Manufacturing with quality control of GMP documentation, change control and CAPAs.
- Quality control and coordination of GMP documentation in B90 (BPRs, SOPs, logbooks, etc.)
- As per quality operating procedure for Batch Production Records (BPRs) review, logbook review and sterilization records review, in collaboration with quality manager, ensure requirements for documentation of manufacturing operations are met. This includes:
- Review BPRs and Logbook documentation in real-time when applicable,
- Coordination of corrections if any, And progress tracking (BPR tracking file for BPR).
- Update of SOPs and GMP Documents
- Quality / Project management (Change Control & CAPA system)
- Initiate and manage change control or CAPA requests affecting the B90 department. This includes presenting change control to the change control board.
- Collaborate with assessors from different functions within IO (quality, MTech, engineering departments) and outside IO (regulatory affairs) for evaluation of changes.
- Ensure timely closure of change controls or CAPA, including following up on the actions under other departments’ responsibility.
- Support Lead Investigators and B90 manufacturing in establishing change controls approved for execution or CAPA in a very short timeframe to support closure of Quality Notifications.
- B90 representative for Site Wide Initiatives/ Continuous Improvement projects related to Quality Systems, Processes and Procedures.
- Perform and/or participate in GQD gap analysis for the B90 Department.
- Identify opportunities for process improvements, applying lean methodology
- Technical Writing / Assist SMEs in authoring GMP documentation
- Work with SMEs to draft or revise GMP documents (SOPs, SWIs, protocols, or reports)
- Assist with document management in Quality eDoc system
- Add tables, figures, photographs where required
- Perform quality checks on documents (to comply with formatting requirements)
- Follow-up on the review and approval process to expedite document approval when necessary
- Point of contact for Record & System Office
- Performance metrics
- Prepare performance weekly Metrics reports for B90.
- This includes data consolidation and metrics analysis with associated remediation plan when needed for change control performance, CAPA performance, GMP documentation tracking tool and SOP management.
- 4-year Bachelor’s degree in Science
- 1-2 year experience in GMP environment
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Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto
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