Operational QA - Irvine, United Kingdom - GSK

GSK
GSK
Verified Company
Irvine, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Site Name:
UK - North Ayrshire - Irvine


Posted Date:
Feb


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 million 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.


Operational QA
The role holder will be responsible for the release of raw materials, starting materials, intermediates, drug substance and blends.

The role holder is key in the management and governance processes providing overall quality assurance


Responsibilities:


  • Release raw materials and products for downstream manufacturing to ensure all quality standards and market restrictions are met and appropriately signed off
  • Approve master batch sheets, SOPs, specifications and methods to ensure compliance with GMP and licence registrations
  • Participate in Operational Quality approval of changes in a compliant manner to ensure that proposed changes are planned and evaluated
  • Plan, conduct and document internal quality audits to ensure GMP compliance
  • Evaluate site Right First time performance and drive improvements in the RFT figures
  • Participate in assessment of nonconformances with cGMP, deviations and customer complaints investigations and ensure that appropriate CAPA has been identified and verification of CAPA effectiveness and deviation trending is carried out.
  • Complete product stability protocols and periodically evaluate the stability profiles to ensure the quality of the products manufactured
  • Provide support and advice both informally and through quality councils to Operations to ensure continued business compliance
  • Review of batch documentation, test results and all other documentation associated with certification (for EU) and release of Finished Product
  • Provide Batch certification for release.
  • Review and approve of Technical Terms of Supply (TTS) and associated quality agreements to include review and approval of changes and assessment of deviations and trends
  • Approve distribution risk assessments to assure compliance with cGMP.

APPLICATION CLOSING DATE -
7th March 2023
Please take a copy of the Job Description, as this will not be available post closure of the advert.

LI-GSK


_ Why you?_


Here at GSK, we are seeking someone that is passionate and able to 'roll up their sleeves' when needed and in return we will offer fantastic career progression and the opportunity to engage with Senior Stakeholders, allowing you to shape and contribute to the success of the business.


Basic Qualifications**:

  • We are looking for professionals with these required skills to achieve our goals:_
  • Degree or HNC/HND or equivalent with relevant GMP experience
  • Organisational/decision making skills, excellent communication skills (both written and verbal) and an ability to manage change
  • Experience within the Pharmaceutical Industry including an indepth knowledge of cGMP/GQLP and Quality issues

_ Why GSK? _


GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.


Find out more:
Annual Report 2021

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns -
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