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Quality Coordinator

Pharmaceutical

Leicestershire
£20k – £21k
permanent
Job Ref: 6938

Description

A growing pharmaceutical company has an exciting opportunity for a QA Technician to join its team. Your role will be to support the QA/QC department in ensuring it meets regulatory and QA guidance for Food Law and EU GMP products. To be considered you must have previous experience in a QC role although experience in QA is highly desirable. You will have a degree in a relevant subject, or have the equivalent lab experience.

Role Description:

A key member of the QA/QC Department who ensure that the company meets regulatory and QA guidance / legislation for Food Law and EU GMP (medicinal products). 

You will ensure the maintenance of Quality Management System ensuring products are manufactured according to requirements.

Duties and Responsibilities

Quality Management System

  • Implementing Controlled Forms, SOPs and Appendices into the QMS system.
  • Reviewing Standard Operating Procedures (SOPs) and updating to cGMP where necessary.
  • Managing the Change control system, ensuring change controls are logged and stages are completed.
  • Raising deviations and non-conformances as appropriate, identifying root cause and necessary immediate corrective actions.
  • Raise CAPAs as required, and implementing assigned actions.
  • Carry out validation activities as required, Assist QM with writing validation protocol for new equipment.
  • Maintaining all databases, files and records
  • Assisting with internal principle-based audits.
  • Suggesting improvements to increase efficiency and ensure regulatory compliance.
  • To review and maintain all relevant Retention systems
  • To review and maintain and work through change controls, deviations, exceptions, CAPA and Complaints.
  • Reporting accordingly on the above
  • Utilise Quality Management improvements and conduct Batch document reviews.
  • To liaise with suppliers on non-conformities and deviations, and to raise deviations as per company SOPs.
  • To liaise with suppliers to obtain documentation required for release of products.
  • To sign off labelling/coding prior to commencement of a run as per SOPs. (within Packing)

Release Process

  • Review of batch documents and release of food supplement batches, including physical release.
  • Review of batch documents for licensed Traditional Herbal Remedy (THR) products prior to QP batch release.
  • Preparation of Certificates of Analysis.

Equipment and Environment

  • Assisting with temperature mapping as required.
  • Ensuring all equipment is uniquely numbered and logged maintaining equipment database.
  • Arrange calibration and performance verification according to schedule. Liaise with suppliers to ensure documentation is correctly supplied, including for the HVAC system.
  • Glass and brittle plastics audits and review and updates when required.
  • Regular walkabouts of facilities making recommendations to ensure continued compliance.
  • Contact for pest control contractor when required.

Samples and Testing

  • Preparing samples and despatching to external laboratories as required.
  • Determine testing requirements for expired stock.
  • To raise any out of specification (OOS)/ Deviations with Manufacturing Supervisor and QA Manager.
  • Resolve any manufacturing issues, testing packaging and help with any supply chain issues to support batch release.
  • To accurately record results obtained from testing for temperature exertion, uniformity of weight, visual inspection, friability, disintegration and hardness.

 Complaint Handling

  • Receiving, logging and investigating complaints.

Miscellaneous

  • Assisting with training where appropriate.
  • Correctly and accurately using the Fusemetrix system.
  • Completing meeting minutes as required.
  • Any other work reasonably required by the QA Manager or Company Directors.
  • To carry out corrective and preventative actions as required.
  • Suggesting improvements to increase efficiency and ensure regulatory compliance.
  • To comply with all QA and QC procedures.
  • To maintain accurate and complete documentation in line with GMP.
  • To monitor and record all necessary Quality Metrics and report as necessary to the Quality Manager.

Essential Skills  / Qualifications

  • Accuracy and Diligence
  • Team-worker
  • Proficient in maths and written/spoken English – to a level required for the role.
  • Experience working in a QA or QC role
  • BSc in a relevant subject
  • Proficient in Excel

Desirable Skills / Qualifications

  • Experience in QA and/or QC within a pharmaceutical or food manufacturing environment
  • Experience working under GMP, ISO9001 or BRC
  • Experience working in a tabletting and/or encapsulation premises

Salary £20k - £21k

Job Ref: 6938