Description
HARVEY NASH is currently looking for a QA compliance validation & project supervisor for one of its customer.
FUNCTION DESCRIPTION
- Provide QA support to validation activities
KEY RESPONSIBILITIES
- Review/Approve IQ/OQ/PQ Protocols
- Review/Approve IQ/OQ/PQ Reports
- Ensure the compliance in all validation activities
- Review/Approve the validation documentation regarding the GMP requirements and the customer procedures : URB - Basic design - Validation master plan
- Approbation of risk assessment
- Ensure timely escalation to Mgt of critical issues during validation and/or project
- Review and approve the potential CAPA plan issued from deviation or inspection
- Contribute to external audit (L3 corporate/L4 Belgium ) : before - during - after
- Ensure implementation of validation related commitments towards internal/external inspections
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
- Provide a compliance expertise in all BU projects
- Ensure QA oversight of GTS Facility project from URS up to SAT
- Ensure the compliance in the Projects
- Attend all project meetings as QA expert
- Ensure the compliance in all future validation activities
- Work in autonomy with supervision/coaching
PREREQUISITES
Education
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Knowledge
- Good interpersonal relationship skills
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented
Previous Experience
- At least 3 years of experience in Validation and QA in a biopharmaceutical industry.(Process Control and CSV Validation, Autoclave and Cleaning Validation knowledge would be considered an added value).