QA Officer

Job responsibilities

• Support the Head of PERL in maintaining the PERL facility and supporting GMP documentation in an MHRA audit ready state. Provide document control for Standard Operating Procedures, Batch Manufacturing Records and Validation protocols.
• Undertake regular review of logs for Micro, Physical and Cleaning Records of the PERL.
• Assist with the preparation and review of manufacturing and validation documentation such as Production and QC batch manufacturing records.
• Lead and act as a QA reviewer and approver for manufacturing and validation documentation, OCC, Dev, CC, CAPA and production records representing the GMP facility
• Act as a point of contact between PERL QA and the PET radiochemistry team.
• Lead internal QA audits ensuring that GMP compliance is met.
• Support the hosting of external audits by regulatory bodies.
• Ensure that the data for the QRM review of OCC, Dev, CC, CAPA, Audit actions/findings, document control/review, training records, EM review, Trending and Maintenance log review are fully documented and available at the time of the QRM.
• Support PERL management quality awareness by bring to their attention significant trends and issues via periodic reporting.
• Identify and assess any non-compliance issues, raise issues with senior/line management and ensure appropriate actions are agreed, implemented and followed up. Be proactive to ensure that regulatory and compliance issues are resolved in a timely manner and do not present barriers to the production of radiotracers.
• Provide advice and guidance on GMP, regulatory and compliance related issues.
• Provide GMP training.
• Research and analyse information from multiple sources in relation to updates to GMP regulations, with a view to amend/modify procedures and interventions in the manufacturing process within PERL.
• Participate and lead in process improvements utilising LEAN principles based on views from users and conveying the detail and rationale in a clear way
• Be proactive in providing quality support for the implementation of new radiopharmaceuticals to the PERL.
• The post holder will be required to work with minimum supervision. They must be able to manage their own time and workload efficiently and effectively. This also requires a confidential and methodical approach with a flexible and adaptable work ethic. They will interlink with other areas of the PET Centre and research groups within the School of Biomedical Engineering and Imaging Sciences and will be required to communicate with them effectively.

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

Person Specification

Experience

Essential

• Experience working in QA in a licensed pharmaceutical production unit
• Experience of aseptic production processes

Desirable

• Trained auditor, with experience of supplier audits
• Supervisory experience and training and mentoring skills
• Experience with automated synthesis equipment

Qualifications

Essential

• Higher degree (e.g. MSc/PhD or equivalent) in chemistry, pharmacy or related discipline or significant relevant experience of 3 years plus in a QA position

Knowledge and skills

Essential

• Knowledge and application of GMP, GCP, QA and current pharmaceutical legislation
• Demonstrated ability to manage quality exceptions and knowledge and application of a pharmaceutical quality system
• Excellent verbal & written communication skills including ability to draft documents, e.g., standard operating procedures
• Project management skills, with the ability to handle several projects at once and prioritise workload, acting on personal initiative and take responsibility for own work to ensure projects are completed
• Experience of meeting targets and deadlines
• Strong interpersonal and networking skills, working as part of a multidisciplinary team, flexible approach to hours & duties and ability to work with a variety of people and positive constructive and team-based approach to problem solving

Desirable

• Good knowledge of validation including cleaning validation, method validation and CSV
• Knowledge of PET and/or SPECT radiotracer synthesis and QC within a Radiochemistry laboratory experience

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

Kings College London

Address

St. Thomas's Hospital

249 Westminster Bridge Road

London

SE1 7EH

Employer's website

https://www.kcl.ac.uk (Opens in a new tab)