Site Conformance Primary Senior Specialist
il y a 2 semaines
**Site Name**: Belgium-Wavre
**Posted Date**: May 17 2024
**Please note that this is a 6-months contract.**:
**_ Site Conformance Primary Senior Specialist _**:
**Job purpose**:
European cGMPs (Eudralex vol4) define that the purpose of controlling batch release is to ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorization, the principles and guidelines of Good Manufacturing Practice and any other relevant legal requirements before it is placed on the market.
Our principal duty as the Site Conformance team is to:
- Ensure as quality representative, compliance to regulatory dossier of activities related to Manufacturing Units or Quality Control Department.
- Support any change evaluation related to Manufacturing Units or Quality Control regarding regulatory dossier or GMP compliance.
- Support any evaluation related to deviations from Manufacturing Performance Units or Quality Control on Regulatory matters.
- Ensure the regulatory oversight within Manufacturing Units or Quality Control Department. By ensuring this duty, we contribute to avoid supply issue, delay or recall due to misalignment to file.
**In this role you will, you will have the following responsibilities **
Provide Chemistry/Manufacturing/Controls (CMC) and regulatory expertise within Manufacturing Units or Quality Control Department
- Ensure continuous alignment of Operations with the approved data by Health Authorities.
- Constantly be aware of new regulation and guidance regarding regulatory compliance.
Support Manufacturing Units or Quality Control Department for CMC processes
- Be responsible of quality oversight of source documents and ensure providing the operational documents to support GRA in authoring post approval changes' variations.
- Internal review and approval, on behalf of Operations, of submitted documents to Health Authorities in the frame of Regulatory Submission Process.
- Lead Questions & Answers and Commitments process within Manufacturing Units or Quality Control Department.
- Support the Head of site conformance in developing regulatory awareness of Manufacturing Units or Quality Control Department on systems/ processes linked to the alignment of file to operations (regulatory purpose, change management, commitments, documentation, process review, regulatory submission, Question and Answer process.
Support GRA team for MU/SU processes:
- Support the Head of site conformance in coaching and developing awareness of GRA team over MU/SU shop floor practices.
Change Control
- Be responsible for initial assessment of the potential regulatory impact of changes.
- Support the Head of site conformance in defining GRA regulatory strategy on behalf of Operations
- Support Operations in defining implementation and release strategy with regards to Regulatory matters.
Support MU/ QC head and QA head by being the Single Point of Contact (SPOC) for any decision related to regulatory compliance.
- More specially, support them in the deviation process in case a regulatory impact has to be confirmed.
- Support the MU/ QC during the audits and inspections and to help inspection readiness.
Provide CMC and regulatory conformance expertise to support release of products
- In compliance with marketing authorization through deviation assessment, visibility to registered details, post approval changes guidance.
Support QMS process and help establishing a strong QMS understanding in Manufacturing Performance Units or Quality Control Department
**Why you?**
- Qualifications & Skills: _
- Master Degree or PhD in Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline
- Minimum 7 years in Pharmaceutical Industry (preferably in an FDA approved context) including strong GMP knowledge & experience
- Technical understanding of product manufacturing processes and/or testing
- Fluency in French and English
- Preferred Qualifications & Skills:_
- Strong team spirit behavior
- Lean culture spirit
- Ability to work across boundaries
- Good communication and coaching skills
- Leading and influencing capabilities
- Flexible thinking and ability to support changes
- Assertive
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.
**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
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