Provide quality oversight for manufacturing process equipment, CIP, SIP, Thermal, Utilities, HVAC qualification and computerized system validation activities pertaining to B100 licensure, start-up and lifecycle management.
Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.
Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.
As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance.
Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.

Essential skills and knowledge

Bachelor's Degree in Engineering / Science or related field
4+ years of experience in a GMP controlled environment/pharmaceutical industry
Experience with qualification of manufacturing process equipment is required (examples of manufacturing equipment include: Isolators, Fermentors, Microfiltration and Ultrafiltration systems, Centrifuges, Microplate Readers, etc.)
Experience reviewing documentation for completeness, reviewing reports and non-conformances/deviations, administrative tasks and leading meetings.
Experience with computerized systems validation is required
Validation experience from MSAT or quality side, conducting validation studies 3
Biologics or vaccines experience would be a plus
Experience with qualification of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset
Technical writing, effective oral and written communication skills, and strong compliance mindset.
Good understanding of current and evolving regulatory requirements
Strong communication, negotiation, and interpersonal skills and teamwork
Good interpersonal and influencing skills are important for a candidate's success
Ability to anticipate evolutions due to internal and external factors.
Conflict resolution and problem-solving.
Familiarity with strategic planning, balanced judgment and risk analysis.

Related tags

JOB SUMMARY

Quality Manager (Engineering)

Toronto

10 hours ago

Entry / Junior

Full-time