Supplier & Incoming Materials QA Specialist
il y a 1 semaine
As a, we empower you to be yourself, share ideas and work collaboratively
_ Supplier & Incoming Materials QA Specialist_:
Job purpose:
- Maintaining "auditee" (supplier) profiles in the relevant data systems per procedures
- Collecting, reviewing and maintaining applicable compliance documentation for in scope suppliers including negotiating Quality Assurance Agreements with suppliers and service providers
- Generating relevant metrics, data analytics and trending for performance management
- Managing supplier and site notification in mailboxes
In this role you will
- Solicitate, collect, negotiate and review proactively quality agreements in partnership with key stakeholders (procurement/ TLCM/ manufacturing sites). Approximately quality Agreements to manage.
- Generate and manage the annual Quality Agreement plan for GSK Vaccines in partnership with GSK Pharma and R&D.
- Escalate any quality agreement issues to direct management and supplier quality operations team for further negotiation with suppliers
- Compile and coordinate risk assessments related to Quality Agreements issues.
- Obtain and maintain relevant supplier information in company systems in a systematic manner to allow for effective and efficient utilization of supplier data.
- Maintain the supplier profiles in the relevant data systems and ensuring that all applicable data associated with the supplier are kept current based on currently available information. Obtain and compile relevant metrics for data analytics and trending for performance management of suppliers
- Monitor of all mailboxes, including any required logging onto applicable systems and data bases (e.g. supplier and sites notifications).
- Be responsible for providing relevant support to GSK sites undergoing regulatory/ customer inspections.
- Participate, as applicable, in the development of internal Supplier Quality (SQ) processes to ensure compliance with the GSK QMS (Quality Management System).
- Collaborate in the developing and performance monitoring of a data integrity improvement plan within SQ Operations (SQO)
- Coordinate the integration of Rosia and Marburg sites within Quality Agreements processes and lead the remediation plan
- Collaborate to ensure data integrity is consistently implemented within SQ Operations (SQO)
- Collaborate to the deployment and execution of the Data integrity plan and deliver associated DI trainings to QSS
- Collaborate in the simplification projects for the Qualification and lifecycle management of Incoming material
Interface
- Routinely interface with site Quality /Procurement, Audit & risk Management, SQ Operations and GSK suppliers — a twoway communication regarding supplier compliance documents, Qualitv aareements, chanae controls, etc
_ This job opportunity is a permanent contract __not_
_ opened for relocation. _
_Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade._
_ Why you? _
- Qualifications & Skills:_
- Bachelor degree or Master Degree in a relevant scientific, quality or technical discipline and relevant experience in (bio)pharmaceutical manufacturing and/or quality operations.
- A good understanding main vaccines/biological products manufacturing processes
- Fluency in English, French is a plus
- Preferred Qualifications & Skills:_
- Good verbal and written communication skills, including ability to progress requests for information in an effective manner.
- Proficient influencing and negotiating skills to ensure collection of desired information from suppliers and user sites while maintaining a good relationship with the supplier.
- Ability and willingness to maintain rapid response to customers, staff and management.
- Strong command of English. Additional language skills would be an advantage.
- Good time management skills to ensure assigned activities and associated documentation are completed within the required timelines.
- Li-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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-
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