Lifecycle Management QA Specialist

2 weeks ago


Worthing, West Sussex, United Kingdom GSK Full time

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 operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.


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.

The way we work will change. For some, the shift in technology and products will be revolutionary.

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
Preferred

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


  • Worthing, West Sussex, United Kingdom Allergy Therapeutics Full time

    About UsAllergy Therapeutics are a market leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.We believe that transformational outcomes for patients are achieved by directly treating the cause, rather than just managing symptoms. Our vaccines are aluminium free. Driving convenience; our...

  • QA Tester

    2 weeks ago


    Worthing, West Sussex, United Kingdom Amber Labs Full time

    QA Tester / QA Test Engineer - Mid-LevelPermanentYou MUST have active DV security clearanceWest Sussex - Hybrid (Office/Remote)QA Tester / QA Test Engineer - Mid-Level Spec**:As a test engineer you will ensure all code is of the highest quality - meeting each ticket's testing requirements before allowing the code to be progressed into production.You will be...

  • QA Release Officer

    2 weeks ago


    Worthing, West Sussex, United Kingdom Hobson Prior Full time

    Salary:£ £40000 per annumJob type:PermanentLocation:Worthing, EnglandFunction:Quality Assurance, Quality SystemsPosted:27/07/2023Ref:BBBH2320- Hi I'mRaif, I manage this roleHobson Prior are currently looking for a QA Release Officer (Steriles) for a brilliant biotech organisation on a permanent basis located in Worthing. Our client is focused on treating...

  • QA Scientist

    1 month ago


    Worthing, West Sussex, United Kingdom Myn Full time

    QA Scientist9 MonthsWorthing£14.12p/h PAYEWho Are We?We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare...

  • QA Scientist

    4 weeks ago


    Worthing, West Sussex, United Kingdom Myn Full time

    QA Scientist9 MonthsWorthing£14.12p/h PAYEWho Are We?We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare...

  • QA Functional Tester

    2 weeks ago


    Worthing, West Sussex, United Kingdom Equiniti Full time

    Management LevelGEQ is a leading international provider of shareholder, pension, remediation and credit technology. With over 5,000 employees, it supports 37 Million people in 120 countries. EQ's purpose is to care for every customer and simplify every transaction, delivered with less of an impact on the environment.EQ's vision is to be the leading global...

  • QA Scientist

    4 weeks ago


    Worthing, West Sussex, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK Group are recruiting for a QC Analyst to join a company in the pharmaceutical industry at their site based in Worthing on a contract basis for 6 months.Salary: Up to 14.12 per hour PAYEQC Analyst Role:To test routine production and stability samples supplied from the site Value Streams and meet testing lead-time targets.Calibrate and maintain analytical...

  • QA Scientist

    1 month ago


    Worthing, West Sussex, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK Group are recruiting for a QC Analyst to join a company in the pharmaceutical industry at their site based in Worthing on a contract basis for 6 months.Salary: Up to 14.12 per hour PAYEQC Analyst Role:To test routine production and stability samples supplied from the site Value Streams and meet testing lead-time targets.Calibrate and maintain analytical...

  • Commercial Specialist

    2 weeks ago


    Worthing, West Sussex, United Kingdom Adecco UK Full time

    Commercial Specialist £30- £35,000 Worthing (Hybrid)Commercial Specialist £30- £35,000 Worthing Working in the office twice per week in Worthing.Our utilities client is currently seeking a As a Commercial Specialist that will be supporting the delivery of commercial management for high value contracts. You will support the Commercial Managers with the...


  • Worthing, West Sussex, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full time

    QA Stability Programme Coordinator This is a site-based role at Worthing. To drive the stability process, ensuring procedures meet process requirements. To assist in identifying batches for stability testing, including the need for stability testing following change control or process deviations and to facilitate their sampling. To manage stability...

  • Automation Test Lead

    2 weeks ago


    Worthing, West Sussex, United Kingdom Equiniti Full time

    Equiniti is a leading international provider of shareholder, pension, remediation, and credit technology. With over 6000 employees, it supports 37 million people in 120 countries. EQ's vision is to be the leading global share registrar, offering complementaryservices to its client base and our values set the core foundations to our success. We are TRUSTED to...


  • Worthing, West Sussex, United Kingdom GlaxoSmithKline Full time

    Site Name: UK - West Sussex - WorthingPosted Date: Jun QA Stability Programme Coordinator Closing Date for Applications - 14th July (COB) This is a site-based role at Worthing.To drive the stability process, ensuring procedures meet process requirements.To assist in identifying batches for stability testing, including the need for stability testing following...


  • Worthing, West Sussex, United Kingdom Advanced Resource Managers UK Full time

    IIOT PRODUCT SPECIALIST - WEST DURRINGTON - PERMANENT - UP TO £53,000 PER ANNUMAdvanced Resource Manages are currently looking for an IIOT Product Specialist for a private utility company for a 6 month contract based in West Durrington.About You: You will have experience in managing a team in IIoT Platforms. You will have experience managing large scale...

  • Task Specialist

    4 weeks ago


    Worthing, West Sussex, United Kingdom Equiniti Full time

    Business Division: Business Function / Department: Job Title: Reporting to (Job Title): Date: Equiniti is a leading international provider of shareholder, pension, remediation, and credit technology. With over 6000 employees, it supports 37 million people in 120 countries. EQ's vision is to be the leading global share registrar, offering complementary...

  • Task Specialist

    2 weeks ago


    Worthing, West Sussex, United Kingdom Equiniti Full time

    Business Division:Business Function / Department:Job Title: Task SpecialistReporting to (Job Title):Equiniti is a prominent global provider of shareholder, pension, remediation, and credit technology. With a workforce of over 6000 employees, it serves 37 million individuals in 120 countries.EQ's goal is to lead the worldwide share registry industry,...


  • Worthing, West Sussex, United Kingdom Service Care Full time

    Service Care Solutions are looking for a remote Application Specialist for remote role in the UK. This role has been determined as being outside IR35.Primary scope of the role would be:Support new project implementation aligned with business objective and solution architecture. Specify, design and maintain mechanisms for storage and access to both structured...


  • Worthing, West Sussex, United Kingdom Adecco Full time

    IT Security Operations Specialist - £45-£55,000 Working in the office twice per week in Worthing.Your Responsibilities: Respond to incidents and requests assigned to the SecOps team within SLAs 24 x 7 (On call support as part of a managed rota for out of core hours) in line with IT security standards Provide information regarding intrusion events, security...


  • Worthing, West Sussex, United Kingdom University Hospitals Sussex NHS Foundation Trust (279) Full time

    Job summary West Sussex Integrated Sexual Health Service has a new post available based in our Worthing clinic. We are looking for someone who can provide training for those staff undertaking the Diploma in Contraception and Sexual Health whilst also supporting those who are working towards STIF competencies. Training is also offered to external post...

  • Product Specialist

    2 weeks ago


    Worthing, West Sussex, United Kingdom Southern Water Full time

    Closing Date Job Title: Product Specialist OT - Telemetry Location: Falmer (Brighton) or Durrington (Worthing) Contract Type: Permanent Hours: 37 hours/ week Salary: Up to £56,000 DOE There has never been a better time to join our organisation as we build towards a greener future, tackling climate change, minimising our environmental impact...

  • Purchasing Specialist

    2 weeks ago


    Worthing, West Sussex, United Kingdom Visual Comfort Europe Ltd Full time

    Who we are:Visual Comfort Europe are the premium resource for signature designer lighting. We manufacture and distribute lighting with some of the most influential names in design to the world's best interior designers.We have seen extraordinary growth and are heavily investing in our future. It's an exciting time to join our team where no two days are the...