Lifecycle Management QA Specialist
2 weeks ago
Site Name:
UK - West Sussex - Worthing
Posted Date:
Feb 8 2023
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics.
We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service.
Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.
Find out more:
Annual Report 2021
Lifecycle Management QA Specialist - 12 month contract
We have a new opportunity for a Lifecycle Management QA Specialist to join our team here in GSK on a 12 month contract.
As the QA Specialist you will organise and provide expertise to the site to ensure that all Regulatory changes and Validation operations and exercises are carried out in compliance with regulatory and company requirements.
- In this role you will_
- Organise and lead validation activities in order to provide an effective validation service across routine activities and capital projects.
- Provide input, track and manage the Site Validation Master Plans in conjunction with the Value Stream Validation Teams.
- Write, review and approve validation lifecycle documentation and ensure they comply with relevant GMP/GDP. Validation lifecycle documentation includes Validation Plans, interim and final Validation Summary Reports.
- Organise and lead the Validation Working Party to ensure all key stakeholders, including QPs, remain current with the validation status of new and updated equipment and processes.
- Maintain up to date with industry standard expectations and ensure that both team and key customers are kept informed of changes to validation requirements. Guide, train and mentor individuals / groups involved with the execution of validation activities.
- Maintain finished product specifications to ensure manufacturing and release and end of life testing complies with registered details and pharmacopoeial requirements.
- Maintenance of Manufacturer's Licence, Site Master File and API Manufacturers, Importers and Distributer's Licence
- Generate, review and approve all regulatory documents (submissions, variation dossiers, licence renewals, response to questions and annual reports) to meet GSK submission & launch dates and without undue regulatory restriction on company operations.
- Manage, prepare, approve and maintain Quality Agreements and Technical Terms of Supply with GSK Worthing customers and suppliers, in accordance with the specified processes.
- Promote QRI (Quality regulatory Intelligence) and ensure Pharmacopoeial compliance
- Ownership and oversight of the site Change Control process.
- Ownership & oversight of QC Lab equipment access administration.
- Ownership & oversight of the Kneat evalidation system.
_ About Worthing Manufacturing Site:
_
_ Closing Date for Applications:
Wednesday 22nd February 2023 (COB)_
Please take a copy of the Job Description, as this will not be available post closure of the advert.
_ Why you?_
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Degree in a scientific or engineering discipline.
- Good knowledge of GMP/GDP within a Pharmaceutical Environment
- Advanced knowledge of at least one of the following: Process Validation (including continuous verification), Regulatory Affairs, Laboratory AEQMS & Access control, CSV/ IT Validation, Complex automation Validation, Cleaning Validation
- Ability to build networks, to secure buy in and support for plans and ideas
- Develops new ideas and solutions about specific issues
- Proven track record of problem solving
Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- MSc or PhD in a scientific or engineering discipline
- Awareness of how the impact of technical changes can affect the quality of the product, any impact to the overall order fulfilment process and suggest how the impact can be minimized.
- Experience and knowledge of GMP, safety and environmental regulatory requirements.
- Working knowledge of relevant Site systems, e.g. MERPS, VQD
- Strong interpersonal skills applicable across value streams and departments
- Ability to train and mentor people involved with the execution of validation activities.
- Ability to plan, organize and control workloads of self to meet deadlines and deliver schedule and tar
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