QA validation specialist

Conteúdo do emprego

We are looking for a QA Validation specialist for one of our clients based in Wavre.

Don’t hesitate to contact me : delphine.vanriet@professionals.randstad.be Life Sciences Wallonie

This is a contract as a Consultant (employee or freelancer): to start in September 2024 and to end on 31/12/2024

Our client is a global vaccine research, development and production company, that employs over 90,000 people worldwide, of which 9,000 in its three Belgian sites: Rixensart, Wavre and Gembloux.

Notre client est une entreprise qui recherche, développe et produit des vaccins. Elle emploie environ 90,000 personnes dans le monde et près de 9,000 personnes sur ses 3 sites belges: Rixensart, Wavre et Gembloux.

Job description

As a QA Validation specialist, your tasks will consist of:

• Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
• Review/Approve the validation documentation regarding the GMP requirements and our client’s Vaccines procedures
• Ensure that production practice are aligned with validation conclusion
• Attend all project meetings as QA validation representative
• Ensure timely escalation to Management of critical issues during validation
• Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
• Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
• Work in autonomy with supervision/coaching
• To define the validation strategies through the change control process
• To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
• To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
• To support the production, QA and technical service teams in the implementation of the validation activities.

As a QA Validation specialist we expect the following competences and skills :

• Required Experience & Knowledge
• Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
• Knowledge of GMP / CFR / Eudralex …
• Knowledge of different regulations and standards related to validation activities (VP, VSR, IOQ, VSR, PVR)
• Knowledge of packaging activities
• Knowledge of KNEAT (electronical validation system), MADB (Alarm management database), SAP

Soft skills:

• Good interpersonal relationship skills
• Good oral and written communication skills in French & English
• Problem solving and achievement oriented
• To be a good team player in order to succeed in each validation project and routine activities
• To be able to use a risk-based approach for problem solving and prioritization of tasks

Education, Methodology & Certification Requirements:

• University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)

For this position of QA Validation specialist, we offer an attractive salary with the following benefits:

• Group & hospitalisation insurance
• 7 euros meal voucher per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training

A rate as a freelancer is also possible.