Operational Quality Adviser - Irvine, United Kingdom - GSK

GSK

Verified Company

Irvine, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Site Name:
UK - North Ayrshire - Irvine

Posted Date:
Sep 5 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.

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

In this role you will:

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

Why you?:

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

Preferred Qualifications:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

Preferably a Qualified Person (QP) or working towards attaining this.
Experience of working in the GMP operational environment.
Experience in systems utilized for role, such as SAP / M-ERP.

Closing Date for Applications - 19 of Sept
Please take a copy of the Job Description, as this will not be available post closure of the advert.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

Why Us?

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 organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of