Site Conformance Primary Senior Specialist

Job title:

Site Conformance Primary Senior Specialist

Company

GlaxoSmithKline

Job description

Please note that this is a 6-months contract.Site Conformance Primary Senior SpecialistJob 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 DepartmentEnsure 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 processesBe 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 ControlBe 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 OperationsSupport 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 productsIn 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 DepartmentWhy you?Qualifications & Skills:Master Degree or PhD in Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific disciplineMinimum 7 years in Pharmaceutical Industry (preferably in an FDA approved context) including strong GMP knowledge & experienceTechnical understanding of product manufacturing processes and/or testingFluency in French and EnglishPreferred Qualifications & Skills:Strong team spirit behaviorLean culture spiritAbility to work across boundariesGood communication and coaching skillsLeading and influencing capabilitiesFlexible thinking and ability to support changesAssertiveIf 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 data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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 a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK 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.

Expected salary

Location

Waver, Waals Brabant

Job date

Fri, 17 May 2024 23:17:16 GMT

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