Pharmacy Quality Control Officer

1 week ago

Colchester, United Kingdom East Suffolk and North Essex NHS Foundation Trust Full time

We are looking for 2 x Quality Control Officers to join our Pharmacy team.

You will be involved working primarily in the Pharmacy Quality Assurance department at the Colchester site, with cross-site working on the Ipswich site.

You will be responsible for the operational delivery of the Quality Assurance requirements for Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) in the manufacture of medicines.

You will be expected to support the Head of Pharmacy Quality Assurance in ensuring that the regulatory requirements and standards set by the Medicines and Healthcare products Regulatory Agency (MHRA) are met for the Manufacturing Specials, Clinical Trials and Wholesale dealing licences held by the Trust.

Applicants should hold a minimum of a bachelor’s degree in the relevant sciences, with GLP and GMP experience.

To provide a specialist Quality Assurance (QA) service for Pharmacy Manufacturing Unit (PMU), Chemotherapy Preparation Unit (CPU), Pharmacy, Trust and external customers.

To supervise rotational Assistants, Technicians, Students and Pre-Registration Pharmacists whilst working in the Laboratory and to provide necessary training to all staff, on the safe use of equipment and on performing Environmental monitoring.

To ensure all activities undertaken, maintain high levels of accuracy and are in compliance with the Medicines and Healthcare products Regulatory Agency (MHRA) requirements, as stated in both Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) guidelines.

One of the largest Trust’s in East Anglia, East Suffolk and North Essex NHS Foundation Trust (ESNEFT) provide hospital and community health services to people living across a wide geographical area. We deliver care from two main hospitals in Colchester and Ipswich, six community hospitals and in patients’ own homes. You will be joining a team of over 11,000 amazing colleagues providing care to 800,000 residents.

Along with supporting you to achieve your career goals we offer a generous pension scheme, 27 days annual leave on commencement (pro rata) and access to a range of NHS discounts. Our Staff Health & Wellbeing programme offer a range of services including mental health support. We offer a range of flexible working opportunities.

Our philosophy is thatTime Mattersto everyone. Across the Trust, we concentrate on improving the things we do and removing those which do not work or cause time delays for our staff and patients.

Please ensure you read the attached information regarding Covid vaccination requirements.

If you are passionate about patient care and want to develop your skills and knowledge then we are keen to hear from you.

To lead in the organisation of annual Stability Monitoring and Shelf-life Validation program and perform testing at specified intervals, on Raw Materials and Pharmacy manufactured Finished Products. To include analysis of product or material, assessment of data and trend reviews culminating in either reduction or extension of product shelf life.

To report any deficiencies/concerns to the Senior QA Team and Production Manager and to perform any remedial action as required.

To be responsible for updating and maintaining the Stability Monitoring and Shelf-life Validation program (electronic) database, ensuring currency and accuracy, interpreting results and trends and to ensure they fall within specified parameters as stated in the GMP guide and in compliance with MHRA requirements.

To ensure new products are entered onto the database, shelf-life monitoring of new products are scheduled and performed accordingly, and any ‘obsolete’ products are recorded and removed

To support the Specialist Quality Control Officer in the day-to-day running of the QA laboratory, including liaising with Senior Pharmacy staff, assigning duties to laboratory staff, dealing with technical enquires and assisting with staff-shortage issues. To deputise for the Specialist Quality Control Officer in their absence to ensure a safe, reliable and efficient QA service is maintained departmental staff rotation meetings as required.

To perform routine stock control checks, expiry date checks and the preparation for disposal of Controlled Drug (CDs) Raw Materials and pharmacy manufactured Finished Products, alongside the Specialist Quality Control Officer. To ensure CD stock levels and disposal of, are accurately recorded, signed and dated; and to report any discrepancies to the Production Manager and Chief Pharmacist (Accountable Officer) immediately, to ensure these are investigated in a timely manner and resolved promptly.
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