QA - Stability Programme Co-ordinator

3 weeks ago

Worthing, 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 storage, labelling and overall stability management of product in chambers. To provide an efficient and accurate sample and stability chamber management service to customers within the GSK network according to ICH, regulatory and capacity requirements. To oversee the planning and strategic management of Stability trials and Stability testing in conjunction with the Value Streams and laboratories at GSK Worthing. To report Stability results in a timely and accurate manner and oversee the Stability Annual Review process.

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

In this role you will:

Be responsible for requesting, receipt and delivery of stability samples. Accountable for the design of Stability Protocols, influencing content and processes and exerting advocacy for regulatory and QMS requirements whilst maximising the business benefit and scientific understanding generated from the stability protocol design. Be responsible for set up and management of stability studies in electronic (LIMS) systems, including troubleshooting as required. Own the process for preparation, labelling and storage of stability samples within temperature and humidity controlled environmental chambers in accordance with approved protocols and procedures. Maintain a Database of samples, pull dates and storage conditions following written procedures and protocols. Manage the capacity for stability sample storage, reliably predict shortfalls, suggest and implement appropriate solutions. Provide first line response to alarms for deviations from set environmental conditions in a timely fashion to reduce adverse effect on the quality control of products. Record and identify actions to address deviations from set temperature and humidity conditions of stability chambers. Approve and report data generated by the laboratories at GSK Worthing. Contribute to the review of laboratory investigations and deviations to identify trends and preventative actions. Manage the Stability Annual Review (SAR) process, ensuring that the programme aligns with the site PPR schedule. Utilise data to provide information and knowledge to support the regulatory dossier. Contribute to Quality Incident investigations. Provide advice and support to the site on stability regulations, maintains current knowledge of best practice and awareness of ICH requirements for stability testing.

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

Bachelor’s degree in a relevant subject or equivalent experience in a role that demonstrates technical understanding of equipment and processes. Strong experience within a Stability related job role. Evidence of report writing skills. Knowledge of global stability regulations. Extensive experience in the use of appropriate software (eg Statistica) for the interpretation of stability data and trends. Awareness of the stability requirements necessitated by the change process and the impact on business processes of delays.

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

Working knowledge of relevant Site systems, e.g. LES, SAP, VQMS.

About Worthing Manufacturing Site:

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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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