Walloon Brabant – Contracting
#QA #validation #oversight #validationplan #pharma #gmp
You have experience in quality assurance and/or in validation within a pharma company ? You are quality oriented? Keep reading your future job description.
Our partner is looking for a QA Validation to join its team. This international company is well-known for its pharmaceuticals and vaccines.
- Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
- Review/Approve the validation documentation regarding the GMP requirements and the company procedures
- Ensure that production practices 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
- 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.
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy,…)
- Former relevant industrial experience related to validation and QA in a biopharmaceutical industry
- Knowledge of GMP / CFR / Eudralex …
- Knowledge of different regulations and standards related to validation activities
- 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
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.