QA Validation
il y a 3 semaines
3 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Jefferson Wells Belgium
Fueling business growth within Life Sciences | Business Consultant Life Sciences Jefferson Wells.QA Validation
Our partner is looking for a QA Validation to join its team.
Your responsibilities?
- To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP)
- To define the validation strategies through the change control process (change control & MO notification) - Remark : No signature as task approver/stakeholders.
- To write and implement some validation documentation (VP, VSR)
- To review and approve specific qualification and validation documentation (IQ, OQ, PQ, Risk Assessment, Periodic validation review - Remark : No signature as final approver for equipments with high criticality.
- To ensure the correct application of the validation quality systems on the field and to define improvement plan as required
- To support the production & technical services teams in the implementation of the validation activities
- To ensure an efficient and compliant CVP implementation
- To provide a compliance and business expertise for some specific technical subjects
- The responsibilities of the QA Primary Validation are among others:
- Challenge, review and approve qualification and validation (IQ,OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the companies Vaccines standards and procedures
- Write some validation (VP, PQ, VSR)
- Review & approve (not as final approver) Periodic Validation Review documentation according to the Companies Bio standards and procedures
- Ensure timely escalation to Management of critical issues during validation and/or project
- Pro-actively identify potential quality and compliance risks and be pro-active in escalation.
- Attend all project meetings as QA expert from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics.
Your profile?
- Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety
- Use a risk-based approach for problem solving and prioritization of tasks
- Blow a quality and compliance mindset through the validation activities
Our offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Adela Amzert at adela.amzert@jeffersonwells.be
Seniority level- Associate
- Full-time
- Quality Assurance
- Industries
- Pharmaceutical Manufacturing
-
QA Engineer
il y a 1 semaine
Liège, Wallonie, Belgique CONSULTYS BENELUX Temps pleinCONSULTYS BENELUX is looking for a QA Engineer to reinforce its consulting team.The role of an QA Engineer is to act as the day-to-day liaison with internal and external customers for quality-related activities and ensure GMP compliance of products manufactured and/or tested at a contract facility.YOUR MAIN DUTIES:Ensure all aspects of product manufacturing...
-
QA Engineer
il y a 2 semaines
Liège, Wallonie, Belgique CONSULTYS BENELUX Temps pleinCONSULTYS BENELUX is looking for a QA Engineer to reinforce its consulting team. The role of an QA Engineer is to act as the day-to-day liaison with internal and external customers for quality-related activities and ensure GMP compliance of products manufactured and/or tested at a contract facility. YOUR MAIN DUTIES: Ensure all aspects of product...
-
QA Engineer
il y a 1 semaine
Liège, Wallonie, Belgique CONSULTYS BENELUX Temps pleinTalent Acquisition Specialist at Vulcain Engineering / Consultys BENELUXCONSULTYS BENELUX is looking for a QA Engineer to reinforce its consulting team.The role of an QA Engineer is to act as the day-to-day liaison with internal and external customers for quality-related activities and ensure GMP compliance of products manufactured and/or tested at a...
-
Quality Assurance
il y a 3 semaines
Liège, Wallonie, Belgique Trasis Temps pleinSterility Assurance & QA Validation ManagerAs a Sterility Assurance and QA Validation Manager, you are responsible for the QA validation, qualification, and CSV execution and oversight to ensure the quality of these areas at Trasis Group. You ensure that both internal sterility assurance standards and external regulatory standards and guidance are...
-
Sterility Assurance
il y a 1 semaine
Liège, Wallonie, Belgique Trasis Temps pleinSterility Assurance & QA Validation ManagerAs a Sterility Assurance and QA Validation Manager, you are responsible for the QA validation, qualification, and CSV execution and oversight to ensure the quality of these areas at Trasis Group. You ensure that both internal sterility assurance standards and external regulatory standards and guidance are...
-
QA Compliance Manager, Liege
il y a 1 semaine
Liège, Wallonie, Belgique TN Belgium Temps pleinUne société biopharmaceutique en pleine croissance et présente mondialement.La principale responsabilité du rôle est de gérer les ressources et les programmes pour assurer la conformité à toutes les exigences cGMP et ISO applicables, tout en gérant les fonctions critiques de conformité telles que les systèmes qualité, le contrôle des...
-
Engineer in opleiding
il y a 2 semaines
Liège, Wallonie, Belgique CONSULTYS BENELUX Temps pleinCONSULTYS BENELUX is looking for a QA Engineer to reinforce its consulting team. The role of an QA Engineer is to act as the day-to-day liaison with internal and external customers for quality-related activities and ensure GMP compliance of products manufactured and/or tested at a contract facility. Ensure all aspects of product manufacturing and/or...
-
Business & Functional Analyst ( BPMN, API , FR /EN )
il y a 1 semaine
Liège, Wallonie, Belgique Select Human Resources n.v Temps pleinEn tant que Business & Functional Analyst, vous participez activement à la vie des produits et à la mise en œuvre de ces produits chez vos clients. Vous rejoindrez une équipe pluridisciplinaire et serez en charge de spécifier les fonctionnalités de l'outil en fonction des besoins du client et des contraintes techniques. Vous participez également à la...
-
Project Engineer
il y a 1 semaine
Liège, Wallonie, Belgique Covartim 2021 Temps pleinAn adventurer exploring the MedTech world and all its opportunitiesYou know that you want to be involved in the development of medical technologies, but you do not know what could be your role?You agree that working on many aspects of a project from R&D, to quality, regulatory and clinical topics would be a great opportunity?You would like to explore all the...
-
Sterility Assurance
il y a 1 jour
Liège, Belgique Trasis Temps pleinAs a Sterility Assurance and QA Validation Manager, you are responsible for the QA validation, qualification and CSV execution and oversight to ensure the Quality of these areas Trasis Group. You ensure that both internal sterility assurance standards and external regulatory standards and guidance are comprehensively understood and effectively applied...
-
Quality Assurance
il y a 3 semaines
Liège, Belgique Trasis Temps pleinSterility Assurance & QA Validation ManagerAs a Sterility Assurance and QA Validation Manager, you are responsible for the QA validation, qualification, and CSV execution and oversight to ensure the quality of these areas at Trasis Group. You ensure that both internal sterility assurance standards and external regulatory standards and guidance are...
-
Industrialisation Project Leader
il y a 1 semaine
Liège, Belgique BVI Medical Temps plein**Job Requisition No** VN8155**Work Location Name** Belgium - Liege**Worker Basis** Full Time**Worker Type** Employee**Applications Close Date** May 29, 2025**Purpose** - As part of the **Industrialisation team**, the **Senior Industrialisation Engineer** plays a **key leadership role** in designing, developing, and implementing **advanced manufacturing...
