Quality Governance & Partnership Senior Specialist
About the role
Quality Governance & Partnership Senior Specialist
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.
Basic Qualifications & Skills
We are looking for professionals with these required skills to achieve our goals:
- 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.
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.
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
Uniting science, technology and talent to get ahead of disease together.
Important notice to Employment businesses/ Agencies
Not included in the source posting: about the role, benefits.
Skills
Who can apply
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