For one of our clients, a pharma company located in the Walloon Brabant, we are looking for an experienced QA & Validation Consultant.
Job Description
As QA & Validation Consultant, you provide QA support and oversight to validation activities according to our client's validation procedures.
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 our client's 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 our client's 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.
Requirements
- University degree (Biotechnology, Agronomy, Chemistry, Pharmacy or related).
- Existing experience in QA & Validation within a biopharmaceutical industry.
- Knowledge of GMP/CFR/Eudralex.
- Knowledge of different regulations and standards related to validation activities.
- ICT Skills (software, operating systems, hardware, etc.)
- Fluent in English and in French
- Problem solving and achievement oriented
- To be able to use a risk-based approach for problem solving and prioritization of tasks
- Good team player in order to succeed in each validation project and routine activities
Benefits
- A balanced salary package based on your skills and experience
- Hybrid working opportunity
- Permanent contract
