GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK’s blockbuster products, the site contributes revenues of ~$2Bn annually.
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.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
Quality Governance & Partnership Senior Specialist
You will be responsible for managing and maintaining the systems used to release starting materials for our finished products. You will provide expert advice on supplier changes, vendor complaints and Corrective and Preventative Actions (CAPA), this includes the creation and review of Raw Material Specifications alongside the monitoring of the Supplier Quality Workflow.
In this role you will…
- Oversight of new Active Pharmaceutical Ingredients (API)/Raw Materials, raising Change Controls in VQMS and allocating actions to ensure the Supplier is suitable and the material specifications are created.
- Providing annual updates of the Supply Chain Management (SCM) documents in VQD containing all Suppliers of materials for a given product.
- Active management of Vendor Complaints working closely with the suppliers to ensure appropriate actions are progressed.
- Raising, managing and completing Change Controls for progression of new and existing excipients and non-GSK API testing requirements against pharma/regulatory standards.
- Checks on the Supplier of a Packaging or Raw Material to ensure they meet the expected quality standards.
- Creating and approving the relevant Certificate of Analysis (C of A) acceptance reports to allow material deliveries to be accepted. Reports must be reviewed and updated as required.
- Review and update Distribution Risk Assessment (DRA) as required by assessing transportation to site from the Supplier ensuring compliance.
- Reviewing the quality systems in place for Suppliers not within scope of the audit process by performing desktop audits and generating the subsequent reports.
- Creating and reviewing agreements between Suppliers and site for specifications and purchase requirements.
- Ensuring all Suppliers have been audited in accordance with expected frequency, reviewing audits performed and ensuring that the reports are in line with site requirements.
Why you?
Basic Qualifications & Skills
- Degree in Science related discipline or equivalent experience.
- The ability to approach and discuss scientific data.
- Strong communications skills, able to communicate at all levels internally and externally.
- Experience using various electronic systems e.g., SAP.
- Good attention to detail, able to multitask.
We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.
We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people.
Skills
Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Supplier Auditing, Supplier Quality Management, Technical Writing
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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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