Sterility Assurance Expert (SAE) 1 year contract

PUB316125

About this role

About this role

The purpose of this position is to ensure that sterility assurance practices, contamination control practices, environmental and utility monitoring, and environmental and utility validation are appropriately aligned with regulatory requirements and site policies and procedures to ensure the R&D GMP facilities are compliant for the production of Clinical Trial Material planned for 2021-2022. This position requires on-going collaboration with BRD (Bioprocess Research & Development), AnSci (R&D Analytical Sciences), R&D SQO (Site Quality Operations), QOSA (Quality Operations Sterility Assurance in Industrial Affairs), Facilities and Engineering, and other departments to ensure identified deliverables of the highest level of Quality Assurance are met according to project timelines

• Support Equipment and Facility Upgrades in R&D (50%) scheduled from July 2021 to July 2022• Provide quality assessment of contamination control requirements for changes to equipment and facilities for R&D specific projects (RSVi, MenB, MenPenta, NGF, mRNA filling)
• Review validation documents and associated raw data (for example: protocols, raw data, reports; facility drawings, risk assessments, validation master plans)• Revise environmental SOPs specific for B93 and B60 facilities for monitoring, gowning, flows, cleaning, etc.
• Communicate changes to EM locations (due to validation/qualification) to QOSA and ensure timely updates to databases (for example Master, PharmNetWeb) • Participate as quality representative on facility / environmental related projects captured in line item
• Manage and support the contamination control program in R&D (40%) related to NV projects for 2021-2022
• Approve EM and critical Utility Deviation investigations – conduct process and product disposition and impact assessments• Execution of Sterility Assurance related Global Document gap assessments, in conjunction with VIA Quality colleagues, to ensure alignment of site procedures
• Generate, review & approve environmental/utilities trend reports, as required • Support Self inspections, Global Quality Audits, as required
• Support Sterility Assurance Improvement initiatives that impact R&D facilities/operations in 2021-2022
• Contributes to the completion of identified R&D Quality Plan actions related to Sterility Assurance (Annex 1 – preparation of the Contamination Control Strategy document for R&D facilities)• Support implementation of site-wide contamination control initiatives within R&D, including initiation, review, and execution of change controls to support these changes.

Requirements

Requirements

• Preferred Master of Science in Microbiology/Biology/ Applied Pharmaceutical Sciences/ Engineering• Minimum ten years of work experience in GMP regulated industry, including validation & contamination control experience (for example HVAC & utilities systems, quality design and validation of clean rooms, cleaning & disinfection, environmental monitoring and trending)
• In depth knowledge of GMP compliance regulations as it pertains to aseptic processing and sterility assurance in the biopharmaceutical manufacturing setting • Sound knowledge of sterile drug manufacturing (for example, fermentation, aseptic filling, sterilization methods, isolator & RABs technologies)
• Proficient in use of computer applications (Word, Excel, PowerPoint, Visio, databases)• Experience in performing risk and trend analysis
• Effective time and people management skills to work on projects with different teams, deadlines and priorities

Benefits

Benefits

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Any questions remaining?

Your consultant, Sabrina Morris is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB316125

Account manager

Sabrina Morris
Brunel Canada - Calgary
s.morris@brunel.net

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