Aseptic Services Manager and Deputy Associate Chief

Job description

Job responsibilities

Phase 1 Project Implementation

• To provide leadership and operational support to the technical project lead and deputise in their absence from a technical perspective.
• To prepare and / or approve all procedures, validation documents from a production perspective for submission or amendment upon return from QA lifecycle, general QA and the Technical Project Lead.
• To liaise closely with the Transformation Manager on all aspects of the project timeline to ensure all tasks are scheduled and completed within the expected timeline
• To select contractors to provide the facility ensuring functional specification compliance with the user requirement specifications.To support all procurement processes for the project including qualitative review of tenders.
• To prepare technical summary reports on project progress to be presented at the Phase 1 project meetings and the Aseptic Programme Board.
• To provide operational oversight of contractors for all validation activities required for facility commissioning: IOPQ execution, APS execution and PV activities.
• To review all executed validation and commissioning documentation from a production perspective prior to submission to QA / QA lifecycle.
• To write the facility start up plan for the Phase 1 facility and liaise with existing aseptic services to ensure full integration with other aseptic units
• To represent the facility at new unit inspection prior to facility opening and provide regular updates to Regional Quality Assurance on the project progress.
• To liaise with appropriate clinical teams in Cancer Services, Paediatrics and Advanced Therapies to ensure the facility is able to provide the expected service deliverance and maintain appropriate capacity for the service requirements.
• To prepare and own the facility capacity plan.
• To manage the new product introduction process including process validation.
• To prepare the development strategy to ensure a robust and fit for purpose manufacturing workforce.

Post Project: See details in job description

Person Specification

Qualifications

Essential

• Active professional registration without restrictions with the General Pharmaceutical Council
• Specialist higher degree (Masters) in technical services or quality assurance (e.g. National course in Pharmaceutical Technology & Quality Assurance MSc) or equivalent portfolio of experience

Experience

Essential

• Successful management / leadership at a senior level of aseptic facilities
• Previous assessable experience of managing the introduction, operation and audit of clinical trials according to GMP and GCP
• Previous assessable experience of the design, building, commissioning and qualification of new aseptic facilities and equipment
• Previous assessable experience of developing and expanding technical services to meet specific patient needs and reducing patient risk

Knowledge

Essential

• Advanced knowledge of contamination control requirements within aseptic services and previous experience of developing a contamination control strategies
• Detailed current knowledge of: o EudraLex MHRA and QAAPs requirements, and the British and European pharmacopoeial requirements for raw materials, intermediates, and finished products. o Legislation relating to medicines e.g. HMR 2012/ 1916 o Advanced knowledge of isolators and laminar airflow technology
• Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products
• Knowledge of current best practice in the governance and aseptic preparation of AT(I)MPs

Skills

Essential

• Demonstrated ability to lead, inspire and motivate others to high performance by agreeing clear goals and objectives, providing support and guidance and creating opportunities for development
• Demonstrated ability to provide guidance to the manufacturing teams on solving any mal-functions or problems within the manufacturing facility and ensure outcomes are satisfactory
• Demonstrated ability to evaluate the effect changes in workload, staffing and service development (capacity planning) have on service delivery and to ensure that appropriate actions are applied to ensure that the services operate at low risk to patients at all times
• Demonstrated ability to identify, document, communicate, escalate and manage risks

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).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

St Thomas Hospital

Westminster Bridge Road

London

SE1 7EH

Employer's website

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