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Qa Releaser

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Baxter

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Location:
United Kingdom , Thetford

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This is a critical role supporting the safe, compliant manufacture and release of aseptically produced medicinal products. As a QA Releaser, you will ensure the Compounding Unit operates in full compliance with cGMP, “Specials” manufacturing requirements, local procedures, and corporate policies. You will provide real‑time Quality support during batch manufacturing, ensuring deviations are appropriately managed and decisions are made in line with regulatory expectations. This role is vital in maintaining our “audit ready” culture and ensuring products are released safely, compliantly, and on time.

Job Responsibility:

  • Ensure ongoing compliance of the Compounding Unit with cGMP, “Specials” requirements, and corporate policies
  • Provide QA oversight during aseptic manufacturing, supporting GMP decision‑making and addressing issues in real time
  • Attend Gemba activities to ensure facility and process compliance, identifying and implementing follow‑up actions
  • Maintain and implement EMS and continuous improvement principles
  • Inspect and release final products in line with company procedures
  • Execute timely and accurate batch and documentation reviews
  • Support product release targets and ensure deviations impacting release are fully assessed and dispositioned
  • Complete all Quality System and GMP commitments within agreed timelines
  • Prepare and support Annual Product Quality Reviews
  • Provide QA input into validation activities, planned/unplanned work, and change controls
  • Update SOPs, work instructions, and process documents using DCR and Teamcenter (TCU)
  • Ensure environmental monitoring and equipment calibration schedules are maintained, with OOS/alerts investigated
  • Investigate product complaints and service complaints, ensuring robust root‑cause analysis and effective CAPAs
  • Support supplier complaints, sample management and liaise with Central Supplier Management
  • Support escalations, product holds, and Field Actions
  • Report adverse events to Pharmacovigilance and the Business management representative
  • Ensure production areas remain compliant and inspection‑ready at all times
  • Support internal, corporate, MHRA and third‑party audits
  • Investigate audit findings and implement corrective actions promptly
  • Promote a strong Quality culture across the site and communicate quality expectations clearly
  • Provide day‑to‑day guidance to production teams on GMP requirements
  • Communicate Quality System updates and ensure staff receive required training
  • Participate in EMS initiatives such as 6S audits, GEMBA walks, Kaizen activities, and tier board meetings

Requirements:

  • Degree or BTEC (or equivalent) in a Pharmaceutical or Science‑related discipline
  • Minimum 2 years’ experience in a GMP manufacturing environment
  • Experience in aseptic manufacture preferred but not essential
  • Background in Quality Assurance, Production, Validation or Microbiology is beneficial
  • Strong work ethic with flexibility to meet business needs
  • Uncompromising commitment to Quality
  • Excellent communication skills at all levels
  • A collaborative, supportive team player
  • Highly accurate with strong attention to detail
  • Analytical mindset with a desire to understand data and identify root causes

Nice to have:

  • Experience in aseptic manufacture
  • Background in Quality Assurance, Production, Validation or Microbiology
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well‑Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 01, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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