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Quality Assurance Operations Manager

1 month ago

Leeds, Leeds, United Kingdom Bionow Full time

Senior Quality Assurance Officer Role at Bionow

**Company Overview**

Bionow is a leading pharmaceutical producer in West Yorkshire, manufacturing numerous household brands and specialist prescription products for the NHS. As a Senior Quality Assurance Officer, you will be based with our rapidly growing team.

**Job Description**

We are seeking an experienced professional to join our QA Operations team as a Senior Quality Assurance Officer. In this role, you will support colleagues in QA and the shop floor, playing a vital part in preparing & reviewing critical documentation and coordinating batch release priorities.

The role entails:

  • Supporting deviation systems and investigations.
  • Implementing and reviewing CAPA effectiveness.
  • Managing customer complaint systems and related investigations.
  • Producing and managing product quality reports and batch certificates.
  • Batch review activities of licensed medicines and medical devices.
  • Quality release of cosmetic and food products.
  • Ensuring all activities, changes to equipment, and working practices align with regulations and guidelines for products including licensed medicines, medical devices, cosmetics, food, and biocides.
  • Identifying improvement opportunities aligned with ISO and defining manufacturing operations to ensure optimum performance.

**Required Skills and Qualifications**

To succeed in this role, you will need:

  • A degree or similar qualification in a relevant subject.
  • Proven experience in quality management and management systems.
  • Familiarity with eQMS/eDMS systems such as SAP, MasterControl, or QPulse.
  • A keen eye for detail and ability to resolve issues effectively.
  • Effective communication skills, enabling engagement with people at all levels.
  • Availability for rotation and night shifts.

**Estimated Salary:** £45,000 - £55,000 per annum, depending on experience.