QA Validation
Contracting – Walloon Brabant
Provide QA support and oversight to validation and manufacturing activities according to validation and production procedures.
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 the Vaccines 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
- 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.
Your profile ?
- 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
- 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
- Sense of urgency
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
- Knowledge of company tools (e.g. SAP, documentum) is an asset.
- English : good
- French : fluent
Our offer ?
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.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Caroline, [email protected]
