Pharmaceutical Production Operator

Job overview

St. Mary’s Pharmaceutical Unit is seeking a motivated and detail‑oriented Aseptic Operator to join our specialist aseptic services team. In this role, you will support the safe and accurate preparation of a range of aseptically produced medicines, including chemotherapy and parenteral nutrition under Section 10, as well as clinical trial products manufactured under Section 37.

Key responsibilities include routine aseptic preparation within cleanroom environments, maintaining high standards of GMP, and ensuring all documentation is completed accurately. You will play an active role in clinical trials activity, including maintaining accountability logs, meeting with Clinical Research Associates (CRAs), updating and organising trial master files, and supporting the upkeep of the clinical trials capacity plan.

We are looking for an individual with excellent attention to detail, strong organisational skills, and the ability to work effectively within a multidisciplinary team. Prior experience in aseptic services is desirable but full training will be provided.

If you are committed to patient safety, quality, and continuous improvement, we would love to hear from you.

Main duties of the job

Production Operator supports with the pre-process accuracy checking, manufacturing/preparation and visual inspection of aseptically prepared medicines, non-sterile and terminally sterilised medicinal products, under a MHRA Manufacturer’s “Specials” authorisation or under Medicine Act 1968 (Section 10 exemption) to ensure delivery of a timely, high quality and patient-focused service to Cardiff and Vale.

Undertake clean room activities using aseptic techniques and semi-automated equipment to batch manufacture or prepare patient specific medicines in accordance with clean room behaviour principles.

Undertake manufacture or aseptically prepare medicinal products, including systemically administered anti-cancer therapies, CIVAS products, Parenteral Nutrition, Investigational Medicinal Products (IMPs), Advanced Therapy Medicinal Products (ATMPs), and Non-sterile and Terminally sterilised products depending on the areas of work allocated to the post.

Participate in the Pharmacy Quality Management System, undertaking pre-process accuracy checking and visual inspection activities to ensure the medicinal products are safe and effective for patient use.

Participate in maintaining effective stock control, security and minimising waste of starting materials and consumables required for individual batch production. Will involve wearing specialist clean room clothing for most of their shift.

Detailed job description and main responsibilities

You will be able to find a full Job description and Person Specification attached within the supporting documents or please click "Apply now" to view in Trac.

To participate in the manufacture or preparation and supply of medicinal products, in accordance with good manufacturing practice (GMP), good clinical practice (GCP) and good distribution practice (GDP) requirements, Health and Safety at Work, Control of Substances Hazardous to Health (COSHH) and Ionising Radiations regulations (Medical Exposure) Regulations (IR(ME)R), The Human Medicines Regulations, and any other relevant statutory requirements.

You will be able to find a full Job description and Person Specification attached within the supporting documents.

The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.

Applicant requirements

Welsh language skills are desirable