QA Officer (maternity cover)

Job description

Job responsibilities

Key responsibilities

• Support the Head of PERL in maintaining the PERL facility and supporting GMP documentation in an MHRA audit ready state.
• Provide document control over Batch Manufacturing Records and Validation protocols.
• Conduct Supplier reviews of new and current suppliers and overall provide oversight of all suppliers.
• Generation, preparation and review of batch manufacturing records
• Release of Radiotracers.
• Provide oversight of the PQS items ensuring Deviations, Change Controls and CAPAs are closed out in a timely manner.
• Provide a holistic approach to quality risk management, root cause analysis and FMEA processes and how this is applied throughout the lifecycle of a product.
• Provide oversight of the Site Validation Master Plan, writing and review of Validation protocols
• Review and update of Standard Operating Procedures
• Lead internal QA audits ensuring that GMP compliance is met.
• Support the hosting of external audits by regulatory bodies.
• Act as a point of contact between PERL QA and the PET radiochemistry team.
• Provide QA training/ support and development to others within the PERL Team
• Deliver GMP training.
• 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.
• 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 & 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.

This post will be offered on a fixed-term contract to cover maternity leave (for up to 12 months)

This is a full-time post

This post is subject to Disclosure and Barring Service and Occupational Health clearance

Person Specification

Experience

Essential

• Knowledge and application of GMP, GCP, QA and current pharmaceutical and Specials legislations
• Demonstrated ability to manage Deviations, CAPAs and Change Controls
• Demonstrated knowledge and application of a pharmaceutical quality system.
• Experience in leading qualification/validation activities
• Experience working in QA in a licensed pharmaceutical production unit.
• Experience of aseptic production processes

Desirable

• Good knowledge of validation including cleaning validation, method validation and CSV
• Trained auditor, with experience of supplier audits
• Knowledge of PET and/or SPECT radiotracer synthesis and QC within a Radiochemistry laboratory experience
• Supervisory experience
• Experience with automated synthesis equipment

Other skills

Essential

• Training and mentorship skills
• 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
• Positive constructive and team-based approach to problem solving

Qualifications

Essential

• Education: 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

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.

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)