Our client offers a dynamic range of fully integrated services to meet the complex clinical supply challenges pharmaceutical and biotechnology companies are facing.
The company combines market-leading clinical trial services like comparator sourcing, packaging and labelling with biological sample management. The company delivers tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects
What is your job?
In the framework of the compliance project, the QA validation senior specialist will:
– Put in place an active SVMP and keep it live and up to date
– Ensure the stability of the validation system, sops and templates to lead to performance
– Meet the ever-increasing validation requirements of audits and inspectors
– Use risk-based approaches to make validation activities efficient, cost-effective and defendable
– Take the lead for validation activities from a Quality Perspective
– Analyse and improve the site validation master plan
– Adopt a Risk-based approach to validation activities
Who is the candidate we are looking for?
- Experience in Quality Assurance (5 years)
- Experienced in wide range of validation activities-facility qualification, equipment qualification, process validation, cleaning validation/ verification
- Experience in data integrity and computer system validation
- Experienced in GMP, GDP, and GCP requirements
- Experience in working in a matrix organization
- Excellent communication and intercultural skills
- Team worker and team spirit
- Customer oriented
- High organizational and planning skills
- Work with accuracy and reliability
- Good dose of assertiveness
- Fluent in French and English (any additional language is an asset)