Assistance to the realization of Commissioning Qualification and validation of clean utilities
Required Experience & Knowledge :

• Former relevant industrial experience related to the requested seniority in Validation and QA in the biopharmaceutical industry.
• Knowledge of GMP / CFR / Eudralex …
• Knowledge of different regulations and standards related to validation activities Soft skills:
• 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

Tasks :

Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
• Review/Approve the validation documentation regarding the GMP requirements and the GSK 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.

Job Overview
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