QA officer

Work Schedule

Environmental Conditions

Job 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!