qa validation specialist 105243.

As QA Validation Specialist, you will provide a compliance expertise in validation : 

• Ensure QA oversight in validation activities (IQ/OQ / 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

The requirements for this position as QA Validation Specialist are : 

• Relevant industrial experience in Validation and QA in a biopharmaceutical industry
• Knowledge of GMP / CFR / Eudralex …
• Knowledge of different regulations and standards related to validation activites
• Problem solving and achievement oriented 
• Good oral and written communication skills in French & English
• Problem solving and achievement oriented