Senior Specialist Qc Transfer
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Mar
Are you looking to expand your expertise with technical strategy in a global environment that allows you to keep pace with the speed of change? At GSK, we are transforming how new technologies are used to improve performance across the organization.
Manufacturing capacity outside Belgium has been gradually ramping up with Vaccines sites in Europe, US and Asia and through CMO (contract manufacturing organisations) and Alliances.
In this context, the QC Senior Specialist will be responsible for:- Oversight of Product Transfer projects impacting all GSK Vaccines sites
- Lead complex projects that could have huge impact on GSK business
- Act as key contact for all GSK vaccines sites
- Lead the QC tests transfer activities between GSK-Vaccines Belgium and the other GSK-Vaccines sites (Singapore, Marietta, Shenzhen, St Amand, SB-Biomed, GSAL, Nashik, etc ) and to other external collaborators (licensees or CMOs).
- Organize the QC trainings of GSK-Vaccines and external collaborators from different sites (located abroad).
- Request and coordinate the reagents shipments between sites to support the QC tests transfers, and provide support to lean the shipments process, in collaboration with QC and logistics departments.
- Document these analytical transfers according to the predefined rules
- Lead the transfer of QC analytical tests to our GSK-Vaccines sites (or to external collaborators) located abroad, up to the routine commercial operations (consistency lots), including managing different projects with the workload and resources available, and their specific timelines.
- Implement and communicate the defined harmonized transfer process according to our guidelines.
- Supports project teams and steering committees in setting and continuously reviewing QC tests transfer progress, according to the global project plans, milestones and timelines. Escalate issues when appropriate.
- Establish the Risk assessment specific for the QC tests activities, for all the projects involved.
- Organize the trainings of the external collaborators, required for the QC test methods transfer, in donor site premises, in coll. with the QC commercial department.
- Define transfer success criteria, in collaboration with QC statisticians, QC product coordinators and Quality.
- Write Project Charter (PC) and/or Test Transfer Plan (TTP) at the beginning of a project, or when required.
- Analyze the QC results obtained locally, and write the AMTR (report) documents.
- Ensure a close followup of the QC activities by providing adequate technical support (responses to questions, documentation & SOPs transfer, SOP explanation/translation/clarification, etc. ) for the GSKVaccines sites (and external collaborations), during the QC tests transfer process, in collaboration with QC commercial department (CQC).
- Build his network within GSK-Bio Belgium QC laboratories, in order to guarantee the adequate support for QC tests methods to be transferred locally. Pay attention to the harmonization of the methods between sites during transfer.
_ Why you?_:
Basic Qualifications:
- We are looking for professionals with these required skills to achieve our goals:_
- University degree with scientific background (biology, chemistry, pharmacy,), with minimum 10 years of experience in the pharmaceutical industry and Quality control
- Fluent French/ English (spoken and written)
- Scientific background in chemistry, biochemistry and biology QC
- Good communication and negotiation skills and diplomacy approach when dealing with colleagues within or outside the organization (in Belgium and abroad).
- Good technical writing and teaching skills, good computer skills.
- Good communication and relation skills
- Team spirit and matrix leadership skills
- Project management skills
_ Why GSK?_:
- Our values and expectations are at the heart of everything we do and form an important part of our culture._
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and wellbeing.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and costconsciousness
- 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.
-
Inspecteur Senior QA/qc
il y a 1 semaine
Wavre, Wallonie, Belgique Tec nv Temps plein_**Objectif global de la fonction**:_Le département QA/QC recherche un inspecteur QA QC Senior possédant une expérience solide dans une fonction similaire. L'inspecteur devra à la fois être autonome mais aussi ouvert à progresser et faire progresser une équipe collaborative.- **Missions et tâches**:_L'inspecteur QA-QC réalisera seul et en équipe...
-
Quality Manager Technology Transfer
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-WavrePosted Date: Jun 6 2023Job purpose: In the context of GSK business growth, take responsibility for quality aspects (QA, QC, manufacturing and validation activities) within the groups of MSAT Technical Transfer and External Manufacturing Vaccines. Be accountable from Quality point of view to ensure a successful technical transfer...
-
Qc Ot Security Lab Systems Senior Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-WavrePosted Date: Aug _ QC OT Security Lab Systems Senior specialist_:Job purpose:The Operational Technology (OT) Cybersecurity Officer for Belgium QC:ensures that OT risk is appropriately assessed, prioritized, and mitigated across the relevant lines within this business area.- ensures that centrally defined OT security standards and...
-
Qc Product Coordinator Support
il y a 1 semaine
Wavre, Wallonie, Belgique Jefferson Wells Temps pleinLocation:Wavre#22077QC Product coordinator support:Brabant Walloon - contracting Our partner is looking for a __QC Product coordinator support __to join its team. This international company is wellknown for its pharmaceuticals and vaccines._Your responsibilities?: Write working instructions and procedures related to sample transfer at low temperature...
-
Product Flow Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-Wavre, Italy - RosiaPosted Date: Mar The Product Flow Specialist is a global role across the entire vaccines network with multiple stakeholders both in GVSC (E2E planners, Central Planners, CS, VDCC) and in GIO (production sites, QC, QA,). The main purpose of the role is to guarantee the final container availability for the Pack Schedule,...
-
Senior Qc Export Expert
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-WavrePosted Date: Feb 1 2024About the role:The Sr. expert QC export and Custom is the key actor ensuring that exportation of QC material (Samples, reagents and material) is performed in compliance with local and international regulations. As member of QC logistic leadership team, he supports the QC logistics to ensure and adequate delivery...
-
Technicien(Ne) de Laboratoire Qc-qa
il y a 1 semaine
Wavre, Wallonie, Belgique Laboratoire Huckert's International Temps pleinLe Laboratoire HUCKERT'S International, Laboratoire innovant et présent à l'international. Spécialiste de la bio-décontamination et de la désinfection de haut niveau en milieu médical, pharmaceutique et technologie de pointe recherche pour une entrée immédiate:**TECHNICIEN(NE) DE LABORATOIRE QC-QA (H-F)**Localisation Géographique: Wavre -...
-
Coordinator Qc Release
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps plein_Be You' at GSK_At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.We will be delighted to hear from talented individuals...
-
Project Coordinator
il y a 1 semaine
Wavre, Wallonie, Belgique Pauwels Consulting Temps pleinIn het kortwavrebediende, freelancer40 uur per week Jahlye GeeraertsTalent Acquisition Specialist Life Sciences- Project Coordinator Quality Control: Pharma & Sciences Quality & Compliance Ensure good coordination of QC processes and activities Support the QC team Ensure Quality control within product and development projects Lead projects to achieve...
-
Automation Senior Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinReady to help shape the future of healthcare? Your talent can bring our science to lifeAs a, we empower you to be yourself, share ideas and work collaboratively_ Automation Senior Specialist_:Job purpose:As a Senior Automation Specialist, you are the expert in projects on automation for primary and secondary equipment and systems in GSK Vaccines Belgium...
-
Senior Specialist QA External Manager
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-Wavre, GSK Tres Cantos, MadridPosted Date: Mar _ QA Manager External Manufacturing - CMO _: Job purpose: _ Take responsibility for the Contract Manufacturer Quality oversight quality aspects (QA and QC) within the group of Tech Transfer / External Manufacturing Operations. Ensure the release of the commercial batches in compliance with the...
-
Senior Specialist, Digital
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Wavre, GSK House, Philadelphia Walnut StreetPosted Date: Jul 5 2023The Senior Digital and Innovation Specialist drives the pipeline planning process, including different activities related to identification, idea generation, development and implementation of solutions to address our external stakeholder's needs and improve how we engage with them...
-
Quality Control Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique amaris Temps pleinJob descriptionWe are looking for a Quality Control Specialist for an exciting project involving the technology transfer of new vaccines in clinical phases in a leading pharmaceutical company dedicated to the development and production of innovative vaccines.Mission:In this role, you will play a crucial part in ensuring the successful technology transfer of...
-
Quality Control Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique Amaris Consulting Temps pleinWho are we? :Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...
-
Product Steward
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-WavrePosted Date: Jul _ Product Steward - Project_:Job purpose:Context:This position creation is linked with the WN-436 project. What is the WN-436 project? It is the construction of the new secondary building. This building will be dedicated to freeze-dried products and will have a capacity of 70 million vials. What will be your future...
-
Qualification Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique Pauwels Consulting Temps pleinIn het kortwavrebediende, freelancer40 uur per week Jahlye GeeraertsTalent Acquisition Specialist Life Sciences- Qualification Specialist: Pharma & Sciences Validation Plan, organize and manage Qualification activities (URS, FAT/SAT, IQ/OQ/PQ) Perform Risk Analysis Write and review Equipment or Qualification documents and reports Identify and solve problems...
-
Senior Field Service Technician
il y a 1 semaine
Wavre, Wallonie, Belgique Alyé Temps plein**ENGINEERING****,****JOB VACANCY*******BRABANT WALLON****,****WAVRE*******L'ENTREPRISE**Les collaborateurs de notre client viennent de tous horizons et c'est cette diversité de perspectives et d'expériences qui est la clé de leur succès. Leur équipe LIS (Laboratory Instruments Support comptant 40 collaborateurs), présente sur le site d'une entreprise...
-
Specialist QA Investigational Medicinal Product
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinReady to help shape the future of healthcare? Your talent can bring our science to lifeAs a, we empower you to be yourself, share ideas and work collaboratively_ Specialist QA Investigational Medicinal Product (IMPQ)_:Job purpose: You act with colleagues of CM&S Quality and our partners to ensure the continuous supply of clinical vaccines in line with GSK...
-
QA Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique 1849 GlaxoSmithKline Biologicals S.A. Temps pleinJob Title: Quality Assurance Specialist at GSKMaster the key Quality Assurance (QA) activities related to production, QC, maintenance, calibration, warehouse, CSV, validation, and project activities in your area of responsibilityEnsure timely release of batches of intermediate products related to your area of responsibilityReview and handle deviations,...
-
Sr. Regulatory Affairs Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique Abbott Laboratories Temps pleinFor our Diabetes Care division, we are recruiting a Senior Regulatory Specialist for Benelux.The Senior Regulatory Specialist is responsible for managing an efficient program to ensure that all regulatory activities for Abbott Diabetes Care products are achieved to an agreed schedule.Role and Responsibilities: Formulate, develop and manage a program to...
