Role Overview:
The Quality person in plant is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job duties are performed within a team according to an assigned, production shift schedule. This role will work in shift regimes supporting the 7/7 days cell processing.
Major Responsibilities:
Serves as a Quality person in plant in support of cell therapy manufacturing.
Ensures Quality Oversight in plant covering various process related activities
Performs periodic Quality checks/audits related to process, documentation and process manipulations
Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance.
Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
Review and approve manufacturing procedures and batch records
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
Other duties will be assigned, as necessary.
Profile
Education:
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.
Experience:
A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred.
Key Capabilities, Knowledge, and Skills:
Aseptic processing in ISO 5 clean room and biosafety cabinets.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
Great attention to detail and ability to follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a must.
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
Must exhibit strong leadership skills and effectively develop others.
Ability to collaborate well with stakeholders, customers and peers.
Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
Ability to manage conflict and issues that arise with internal or external customers.
Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
Language Requirements: Dutch and technical English