QA Csv Consultant
il y a 1 semaine
**Your role**
- You will give quality assurance oversight on (IQOQ / PQ ) protocols and reports
- You will help define and support the Validation Approach
- You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP, CFR)
- You will review CSV specific SOP’S and Templates
- You will perform risk assessments
- You will write and approve validation documents (GMP requirements, SOPs, Critical Impact Assessments,)
- You will make sure that production practice are aligned with validation conclusion
- You will communicate to management about issues in the validation process
- You will attend project meetings
- You will provide QA oversight and approve deviation
- You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process
- You will define validation strategies through the change control process
- You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, Periodic review,.)
- You will support the production, QA and technical service teams in the implementation of validation activities
You will work in close collaboration with production, engineering, maintenance, QC, QA
- **Your profile**
- Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains
- French or Dutch fluent and fluent in English
- A minimum relevant experience of 2 years in the (bio)pharmaceutical sector in a computer systems validation role
- Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus
- Good interpersonal relationship skills
- Problem solving and achievement oriented
- Be a good team player in order to succeed in each validation project
Be able to use a risk-based approach for problem solving and prioritization of tasks
- **#LI-CO2
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