Operational Quality Advisor - 14 month contract/ secondment

GSK; Irvine; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading global biopharma company is seeking an Operational Quality Advisor for a 14-month contract in Irvine, Scotland. This role is pivotal in ensuring the quality and compliance of materials and processes, safeguarding patient safety. The ideal candidate will have a degree or equivalent experience in GMP and strong organizational, decision-making, and communication skills. Join us in delivering high-quality medicines and vaccines.

Qualifications

• GMP experience required.
• Experience in the Pharmaceutical Industry with knowledge of cGMP/GQLP.

Responsibilities

• Release raw materials and products for manufacturing.
• Participate in non-conformance assessments and investigations.
• Conduct internal quality audits for GMP compliance.

Skills

Organizational Skills

Decision-Making Skills

Communication Skills

Education

Degree or HNC/HND

Tools

SAP

M-ERP

VQMS

Job description

Operational Quality Advisor - 14 month contract/ secondment

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.

The Operational Quality Advisor plays a crucial role in maintaining the quality and compliance of various materials and processes within the GSK Irvine site. You will be responsible for the release of raw materials, starting materials, intermediates, drug substance and blends. This role is critical for ensuring that the products manufactured by the organisation are safe, effective, and of high quality, ultimately protecting patient safety and maintaining the overall quality assurance.

Key Responsibilities

Release raw materials and products for downstream manufacturing to ensure all quality standards and market restrictions are met and appropriately signed off.

• Participate in assessment of non-conformances 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.
• 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
• 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
• Strong organizational and decision-making skills, excellent communication skills, and ability to manage change.
• Experience within the Pharmaceutical Industry including an in-depth 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:

• Experience of working in the GMP operational environment.
• Experience in systems utilized for role, such as SAP / M-ERP, VQMS.

Closing Date for Applications – 1st June 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. #LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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About the company

GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.