Third Party QA Senior Specialist
- Masters degree in biomedical or biological sciences, chemistry or biochemistry, pharmacist
- Strong experience in regulatory environment
- Fluent English level required
- Strong internal as well as external networking skills to interact with R&D and other departments (eg: Finance, Legal)
- Strong communication and organizational skills
- Has a "can do" attitude, helping the organisation to deliver stretch goals
- Demonstrates integrity, strives for excellence in her/his work
- Availability to travel
- Second language desirable (French/German)
Ensure QA Oversight of third parties involved in the Clinical Manufacturing and Supplies environment.
- Be the SPOC (Single Person of Contact) for all gmp related topic in IT RDC.
- Be the quality contact for the group of third parties he/she is responsible for and for the internal stakeholders involved in activities contracted to these third parties.
- Monitor and manage the quality performance of these third parties, and ensure they operate in compliance with GSK standards and requirements.
- Organize and manage the quality governance meetings for these third parties.
- Write, coordinate and ensure the follow up of the quality contracts approval and update, when necessary.
- Ensure the collaboration with third parties is continuously in compliance with quality agreements and/or other relevant contracts.
- Ensure complaints, deviations, change control, CAPAS, validations related to third parties are handled in a timely manner and in compliance with cGMP's and Quality Contracts.
- Ensure accountability for CAPA closure for regulatory (L4) and corporate audit (L3)
- Ensure accountability for Third Parties data base (Set up, update, …)
- Ensure Quality Systems at CMO site are regularly updated and in line with GSK QMS, through oversight and efficient analysis tool.
- Be part of the third parties selection and approval process, as appropriate. Manage the approval status of these third parties.
- Ensure Issues and Risks are adequately identified, analysed, assessed, mitigated and escalated.
- Be involved in the third parties release certification and re-assessment process.
- Review and approve all the required documentation for the batch release process, and ensure its correct archiving.
- Ensure all the documentation related to these third parties is correctly reviewed, managed and archived according to GSK requirements.
- Be involved in third parties audit organization, preparation and execution, as appropriate.
- Be part of the transfer team for product/process transferred from GSK to a third party and from a third party to GSK.
- Provide a helpful support to CMO in case of issues, in a proactive manner.
- Manage its own performance and contribute to the performance of the QA TPO team in line with the lean culture principles. Drive continuous improvement through KPI and action plans.
- Ensure SOP's and systems related to TPO management are up-to-date and compliant with the current regulatory requirements and regulations.
- Represent QA TPO team at governance meetings, in delegation of the Head of TPO, when needed.
- Travel up to 30% mainly in Western Europe
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Meet Some of GlaxoSmithKline's Employees
Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.
Back to top