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Quality assurance and regulatory compliance officer

Wrexham
Regulatory compliance officer
Posted: 9 January
Offer description

Job Overview It is an exciting time for Pharmacy Technical Services across North Wales. With continued investment and the Transforming Access to Medicines (TrAMS) programme, the future of technical services in the region is bright. We are seeking an enthusiastic, passionate, and self‑motivated individual to join our team, someone who works well with others and shares our commitment to developing the quality and range of services we provide. Recent service investment has enabled us to create a new and dynamic role. This quality‑focused position will support our existing QA and Production teams in meeting regulatory standards, strengthening our pharmaceutical quality systems, contributing to service development initiatives, and supporting education, training, and staff development. Although the post will be based at Wrexham Maelor Hospital, the successful candidate will also provide support to teams across BCUHB. Applicants must have experience working within technical services and be able to demonstrate a sound working knowledge of the regulatory standards the service must comply with. You will be expected to work to a high standard, with strong organisational and communication skills, excellent accuracy, and the ability to use your initiative while meeting deadlines and working under pressure. Pharmacy Technical Services is committed to supporting the training and development of all staff, and you will be provided with opportunities to grow and develop within the role. Main duties of the job Support the maintenance and development of the Pharmaceutical Quality System (PQS) to meet regulatory and licence requirements. Assist with internal audits, validation activities, deviation investigations, and management of non-compliances. Act as releasing officer for manufactured products and respond to MHRA drug alerts, coordinating stock retrieval and quarantine. Provide specialist advice and training on QA processes, environmental monitoring, and compliance with GMP, ISO 17025, and ISO 9001 standards. Oversee QA/QC activities, supervise staff, and plan workloads to ensure timely delivery of services. Manage validation and qualification of equipment and testing methods, ensuring accurate documentation and adherence to ALCOA principles. Interpret and communicate complex test results to internal and external clients, offering guidance on corrective actions. Maintain stock control for QA consumables and equipment, and ensure safe operation of highly complex systems. Participate in quality meetings, audits, and improvement initiatives, supporting education and staff development. Advise on aseptic standards and maintain up-to-date knowledge of QA, GMP, and regulatory requirements. Working for our organisation If you relish a challenge, have a passion to help others or simply fancy a fresh start, then Betsi Cadwaladr University Health Board (BCUHB) North Wales, has all the right ingredients. The largest health organisation in Wales, providing a full range of primary, community, mental health, acute and elective hospital services for a population of around 700,000, across North Wales. Join our team and get the support you need, in line with our Organisational Values and ‘Proud to Lead’ competence framework. Enjoy being part of working with engaged leadership at all levels, and be assured we are committed to promoting equality and diversity, and are proud to welcome applicants under the “Disability Confident Employer” scheme. Please check your email account regularly. Successful applicants will receive all recruitment related correspondence via the email account registered on the application form. The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply. Applications may be submitted in Welsh. Applications submitted in Welsh will not be treated less favourably than an application submitted in English. Detailed Job Description And Main Responsibilities See attached person specification and job description for further details and contact us if you would like to discuss the role further. Person specification Qualifications Essential criteria Relevant Scientific Degree OR BTEC Pharmaceutical Sciences with NVQ Level 3 Pharmacy Services OR The Principles of Aseptic Pharmaceuticals Processing (Level 3). Knowledge of the role and responsibilities of a Quality department in an ISO 17025 laboratory or ISO 13485 and 9001. Knowledge of microbiological principles and aseptic techniques. Knowledge of laboratory instrumentation, analytical techniques and microbiology. Desirable criteria Supervisory/Management qualification. Experience Essential criteria Experience working in a MHRA Licensed Manufacturing Unit or comparable production environment. Desirable criteria Wider experience of pharmaceutical industry including procurement, stores and distribution. Skills Essential criteria Computer skills to include word processing and data entry i.e. spreadsheets and databases. Good numeracy skills including calculations, percentages, decimal, fractions. Manual dexterity to manipulate injections or prepare pharmaceutical products, and good hand-eye co-ordination. Desirable criteria Approachable and professional manner. Ability to remain calm in a busy environment.

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