QA officer
QA officer
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Job Description
Work Schedule
12 hr shift/nightsEnvironmental Conditions
Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed OfficeJob Description
Position Summary:
Thermo Fisher Scientific Inc. offers a groundbreaking chance to join a top-tier team in Swindon UK. As a key part of our Manufacturing team you will be involved in setting up and running our powerful facility. This hands-on role is essential for ensuring high-quality production identifying and solving issues promptly to support efficient manufacturing operations.
Responsibilities:
- Offer quality assurance supervision for operational tasks within the designated team.
- Review sterilization cycles FMS systems and other key controls of clean rooms.
- Manage logbooks and support area controls.
- Perform online review of batch records.
- Close batch records with associates LIMS & SAP transactions and C of A generation.
- Review and update Standard Operating Procedures and Controlled Documents.
- Direct clean rooms and support zones; ensure behavior and conformity to SOPs including entering clean rooms physically and keeping up with at least an L1 license.
- Direct the packaging departments; uphold conduct standards and adherence to SOPs.
- Actively produce and promptly assess minor DRs & CAPA with cell members.
- Produce and promptly evaluate/implement level 0 & level 1 modification controls with cell members.
- Conduct local area and local system audits.
- Train and mentor Operations staff and QA peers.
- Communicate effectively attend Tier 1 meetings and participate in planning and problem-solving activities.
- Offer re-validation resources to the aligned cell effectively.
- Observe incubate read and write reports for media fills.
- Conduct clean room physical checks velocities air patterns DOP tests and particle counting.
- Perform autoclave load pattern re-qualification.
- Test sterilizing filters.
- Validate cleaning processes.
- Conduct AQL-based Visual Inspection.
Experience / Qualifications:
- Preferred relevant science-based degree such as Microbiology Chemistry Biology or Pharmacy.
- Proven experience in the pharmaceutical industry preferably in sterile product manufacture.
- In-depth knowledge and understanding of cGMP and other regulatory guidelines for pharmaceutical manufacturing.
- Excellent interpersonal skills with the ability to challenge behaviors at all levels of the organization.
- Proactive approach to continuous improvement and project work.
Our package includes a variety of adaptable benefits like Pension and Healthcare along with competitive pay. Join our enthusiastic team working towards making a tangible difference in the world!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
