Senior Quality Assurance Officer

Job description

Job responsibilities

Job Summary

The job holder will play a key role in quality assurance of the all medicines manufacturing and preparation activities ensuring a safe, efficient and compliant service.

Duties and Responsibilities

Quality Assurance

1. To be part of the Quality Assurance (QA) team and carry out defined QA responsibilities as defined by the QA rotas.
2. To support the QA team in the delivery of the QA service, meeting the needs of the pharmacy department according to legal requirements and licenses held by the Trust
3. Provide support in the use of our quality management system tool, and assess and act on QA Deviations, Risk Assessments, CAPA, Change Controls and Temporary Changes. To monitor performance against agreed metrics and escalate non-compliance to senior managers.
4. To critically assess deviations, risk assessments, change controls and CAPAs raised by production areas and provide QA sign off. To approve SOPs for use in production areas.
5. Review out of specification physical and microbiological monitoring results and make decisions on suitability of the environment to be used and its impact on product quality.
6. Support the unit teams to become Inspection Ready, particularly in the area of updating of key documents [e.g. SOPs, Specifications, Test Methods].
7. As part of regulatory inspection readiness to ensure document availability and gather documented evidence to confirm resolution of deficiencies identified in our quality system.
8. To assist QA Specialists with auditing activities.
9. To lead on drug defect investigations and drug recalls within the Trust, including complaints.
10. To investigate patient complaints of Trust manufactured products.
11. To undertake validation reviews.
12. To write departmental procedures in line with current guidelines.
13. To carry out log meetings, quality review meetings and monthly trending meetings with production areas as required.
14. To utilise the deviation reporting system and change control system and to trend the data.
15. To be trained to use computerised facility monitoring systems and documentation systems. To act at all times in compliance with data integrity requirements.
16. To act as a releasing officer for all medicinal products manufactured within the Trust and for NHS units with which the Trust has contracts.
17. To be responsible for all interaction with our service provider (Wickham Laboratories) including ensuring samples are sent in a timely manner, result are received and filed appropriately, and any queries from the contractor are resolved.
18. 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 act as releasing officer for ULMs received into the Trust.
19. To respond to queries appropriately.

Quality Control

1. To release raw materials and containers used in the manufacture of medicinal products.
2. To manage to approval of starting material suppliers.
3. To approve QC specifications in line with pharmacopoeial requirements.

Development

1. To investigate and implement the use of an electronic systems including archiving, quality management and manufacturing.
2. To undertake continuous professional development.
3. Assist the QA team in the development of the QA service.
4. To keep abreast of the latest QA guidelines, and ensure that all activities undertaken within the units meet current legislation such as GMP/GDP/GLP, COSHH etc.

Training

1. Assist in the training programme for QA personnel and other pharmacy personnel as required.

Other

1. To undertake other duties as required by the Head of Quality, including project work.
2. To undertake duties as required by lifecycle management team whilst on rotation into that area.
3. To deputise for QA Specialists where required to supervise QA support staff.

Please see attached Person Specification for further information.

Person Specification

Knowledge/Qualifications

Essential

• Degree in Biology, Chemistry, Pharmacy or other related Science OR qualified pharmacy technician

Desirable

• Postgraduate technical services qualification or equivalent experience/short courses.
• Professional registration with a relevant professional body (Royal Soc Bio, Royal Soc Chem, RPSGB or GPhC)

Experience

Essential

• Previous QA experience in a pharmaceutical setting.
• Experience of quality systems and document management systems.

Desirable

• Previous experience working as a releasing officer in a licensed pharmaceutical facility with a comprehensive portfolio of products.
• Previous experience of being audited by external bodies (MHRA, EL etc.)
• Previous involvement in clinical trial product manufacture OR testing according to GMP, GCP, GLP.

Skills

Essential

• 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

Desirable

• Demonstrated practical knowledge of laboratory and microbiological OOS
• Demonstrated ability to identify and manage risks.
• Ability to review and perform QA sign on documents written by others.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Guy's Hospital

London

SE1 9RT

Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)