Senior Quality Assurance Officer - Aseptic Services

NHS; City Of London; On-site; GBP 56,000 - 64,000; Full time

Job summary

A leading healthcare provider in London seeks a Quality Assurance professional to enhance their career in Quality Assurance and Aseptic Preparation. The role involves supporting QA services, leading drug defect investigations, and ensuring compliance with quality systems. Required qualifications include a relevant Masters degree and QA experience in a pharmaceutical environment. The position offers a salary range of £56,276 to £63,176 and is based on-site.

Qualifications

• QA experience in a pharmaceutical setting is essential.
• Experience with quality systems and document management systems.
• Ability to identify training needs of self and others.

Responsibilities

• Support the QA team in delivering QA services.
• Provide specialist quality advice to technical and clinical areas.
• Lead investigations on drug defects and recalls.

Skills

Practical knowledge of GDP, GMP and QA

Ability to produce reports using Microsoft packages

Problem-solving skills

Education

Undergraduate or postgraduate Masters degree in a Science related discipline

Postgraduate technical services qualification

Tools

Quality systems

Document management systems

Job description

Job Summary

We are looking for an enthusiastic, self-motivated and responsible quality professional to develop their career in the evolving landscape of Quality Assurance and Aseptic Preparation, working closely with a variety of teams within Pharmacy.

Previous experience working in the quality assurance field is essential for this role and you will have ideally undertaken quality roles within aseptic services.

The successful candidate will be working in the new St Thomas' Cancer & ATMP Aseptic Units and will be integral member of the teams responsible for ensuring the successful validation and start up of these new facilities and its safe and effective operation.

Responsibilities

• To support the QA team in the delivery of QA services, meeting the needs of the pharmacy department and all associated technical units.
• To provide specialist quality advice to a range of technical and clinical areas within the Trust.
• To support the use of our pharmaceutical quality system tool and to assess SOPs, deviations, risk assessments, change controls and laboratory and microbiological out of specification results.
• To assist with internal auditing and inspection readiness activities.
• To lead on drug defect investigations and drug recalls within the Trust, including complaints.
• To investigate patient complaints of Trust manufactured products.
• To undertake validation reviews.
• To write departmental procedures in line with current guidelines.
• To carry out log meetings, quality review meetings and monthly trending meetings with production areas as required.
• To be trained to use computerised facility monitoring systems and documentation systems.
• To act as a releasing officer for all medicinal products manufactured within the Trust and for NHS units with which the Trust has contracts.
• To provide QA support to procurement and governance teams in the assessment and approval of new unlicensed medicines to be bought into the Trust.
• To support the unit teams to become Inspection Ready, particularly in the area of updating key documents (SOPs, Specifications, Test Methods).
• To assist QA Specialists with auditing activities.
• To respond to queries appropriately.

Person Specification

Essential Knowledge / Qualifications

• Undergraduate or postgraduate Masters degree in a Science related discipline
• Post graduate technical services qualification
• Equivalent demonstrated portfolio of experience and short courses

Essential Experience

• Previous QA experience in a pharmaceutical setting.
• Experience of quality systems and document management systems.
• Previous experience of the investigation, risk and impact assessment of deviations.
• Previous experience of GMP change management.

Desirable Knowledge / Qualifications

• Experience of aseptic preparation of CIVAS, Chemotherapy, TPN
• Previous evaluated experience working as a releasing officer in a licensed pharmaceutical production unit with a comprehensive portfolio of products.
• Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits.

Essential Skills

• Demonstrated practical knowledge of GDP, GMP and QA.
• Able to produce reports, spreadsheets and presentations using Microsoft packages.
• Ability to direct and organise own time and time of others.
• Demonstrated ability to identify training needs of self and others.
• Ability to identify and solve problems.

Desirable Skills

• Demonstrated ability to identify and manage risks.
• Ability to review and perform QA sign on documents written by others.
• Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
• Demonstrated ability to apply the principles of GCP and GMP to the running of clinical trials.
• Familiarity and demonstrated competence with use of computerised software systems for GMP activities and monitoring.

Further Information

• Employer: Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH.
• Salary: £56,276 to £63,176 a year p.a. inclusive of HCA.
• Band: 7. Contract: Permanent. Working pattern: Full-time.
• Reference number: 196-LIS9978D.
• Website: https://www.guysandstthomas.nhs.uk/careers/careers.aspx
• Certificate of Sponsorship: Applications from job seekers who require current Skilled Worker sponsorship will be considered.
• Disclosure and Barring Service Check is required.