Il y a 39 joursAKKA INGENIERIE PRODUIT

QA VALIDATION HF

  • V.I.E.
  • Brussels (Bruxelles-Capitale)
  • Community Management

Description de l'offre

AKKA Belgium is the Belgian subsidiary of the AKKA Technologies Group and currently N°1 in Belgium in Industrial Engineering Consultancy. The company employs more than 800 experts all over Belgium.
For almost 30 years the company has aided the biggest industrial players in all stages of their projects. In doing this we offer a big added value in fast-evolving sectors like aerospace, railway, automotive, life sciences, energy and high-tech. By sharing our expertise with these sectors, AKKA Belgium is helping build the world of tomorrow.
After an annual growth of 10% over the past 10 years, AKKA Belgium has now in two years doubled in size.
JOIN OUR TEAM AS A :
QA Validation
Your responsibilities :
- Provide a compliance expertise in validation
- Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
- Review/Approve the validation documentation regarding the GMP requirements and internal procedures
- Ensure that production practice are aligned with validation conclusion
- Escalate to Management of critical issues during validation
- Contribute to deviation process providing QA expertise
- Identificate potential quality and compliance risks
- Define the validation strategies
- Write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
Your profile :
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
- etc.)
- Former relevant industrial experience in Validation
- Knowledge of GMP / CFR / Eudralex EU, cGMP, PMDA, ICH, PIC/S, WHO
- Good teamwork and organizational skills. Must have strong, organization and analytical skills.
- Facilitator, influencer and planner
- Problem solving and achievement oriented
- Good oral and written communication skills in French & English
AS AN AKKA CONSULTANT, YOU WILL BE :
- In charge of diverse transversal and empowering projects
- Supported in your career by your AKKA Manager
- Actor of your training plan and your personal and professional development
- Member of a dynamic and collaborative community of engineers