Kennziffer der Stelle
Operations — Engineering
3 bis 5 Jahre
Wallonisch-Brabant, Wallonia, Belgien
QA Validation Consultant
For one of our clients, a multinational pharmaceutical and biotechnology company, we are actively looking for a QA Validation Consultant.
Purpose of the Mission
Provide QA support and oversight to validation activities according to validation procedures.
- 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 company’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 reviewing deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities (Approval must be performed by internal employee)
- Pro-actively identify potential quality and compliance
- 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
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
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
SAP, documentum is an asset.
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Language Proficiency Requirements
French - Fluent oral and written communication skills
English - Good oral and written communication skills
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