The Quality Assurance Department at the GSK Ware manufacturing site is responsible for ensuring that all aspects of the manufacture of products is performed in a controlled manner and meets commitments to international regulatory bodies (as well as the requirements of current Good Manufacturing Practice).
The laboratory teams work as part of the Oral & Solid Dose (OSD) Value Stream to ensure that manufactured products are compliant and fit for purpose. This includes product analysis, laboratory investigations, and trend of analytical results.
Job Purpose:
The purpose of the Laboratory Manager is to effectively manage and implement mid to long-term (circa 12 – 18 months) quality management plans for the site's OSD and Raw materials laboratories (to ensure delivery of compliant product to our customers).
The role manages a multidisciplinary team (up to 30 staff – permanent and interim) of Laboratory analysts and team managers.
Key Responsibilities (include):
* Testing and release of materials in line with the Ware manufacturing site’s targets.
* Managing a multidisciplinary team that can comprise of but not limited to Quality Laboratory Teams, Data Analysts, Lab Automation Personnel, Microbiologists and Compliance teams.
* Planning and fronting audits from regulatory bodies (e.g.; MHRA).
* Driving continuous improvement through the whole laboratory to make step-changes in performance.
* Management of EHS performance in the laboratory.
* Planning horizons are operationally in the 12-18 month horizon. Strategically, a plan will be developed to ensure all NPI requirements are completed for the laboratory. This would be integral to the site wide plans.
* Act as an owner of key laboratory business processes including SOP and report author/authorizer.
* Ensure a Self-Inspection program is planned and delivered to ensure that the laboratories are inspection ready.
* Front and manage tours in Level 1, 2 and 3 audits.
* Manage internal audits and ensure all audit actions within agreed timescales.
* All laboratory documentation is maintained in continuous compliance with Company, local, regulatory and pharmacopeial requirements.
* Responsible for the safety of team members, ensuring that housekeeping is maintained, safety procedures are followed, risk assessments are completed and appropriate COSHH controls are used.
As the Laboratory Manager you will have an appreciation of the testing of raw material intermediates and final product testing.
About You:
This role would suit a motivated person who has strong experience of working in a GMP (Quality) environment. Strong people skills and a proven ability to work in a team (e.g.; flexible approach, good communication, planning and organizational skills) are a pre-requisite for the role. An excellent understanding and appreciation of the testing of Oral Solid Dose and Raw products for release is important. You will also have a strong continuous improvement, growth mindset and a willingness to work towards standardized and lean working practices.
Basic Qualifications:
• Relevant qualifications and experience (e.g.; relevant Scientific degree and experience of managing a high-performance team).
• Good knowledge/understanding of laboratory methodologies and understanding of current Good Manufacturing Practice (cGMP).
Preferred Qualifications:
* Strong interpersonal and management skills.
* Able to prioritize and select appropriate course of action.
* Strong continuous improvement mindset.
* Ability to motivate and develop your team members.
* Understanding of laboratory methodologies and analytical techniques related to packaging component testing.
If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.
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