The NUVISAN Group is an internationally successful Contract Research Organisation (CRO) which performs drug trials for international pharmaceutical companies, biotech and generic manufacturers. A complete range of clinical drug development services can be offered as a package including non-clinical services, bioanalytics, biopharmaceuticals, pharmaceutical analysis, stability testing and clinical trial manufacturing and packaging.
Founded in Germany in 1979, NUVISAN’s 420 highly qualified staff provide analytics and clinical studies sponsored by the pharmaceutical industry.
RESPONSIBILITIES
Pharmaceutical activities
Accept finished products, medical devices or commercial products Perform the review of the batch records of the Pharmaceutical Establishment
Upon official delegation from the Qualified Person, perform the release of investigational pharmaceutical products and commercial products
Coordinate the periodic update of the dossier “Etat des lieux de l’établissement pharmaceutique”
Coordinate the follow-up and updates of manufacturing authorizations of the pharmaceutical establishment
Operational activities within the Pharmaceutical Establishment
By delegation of the QP:
Approve subcontracting/client contracts or TQA for GMP/GDP services
Prepare client estimates for QA/QP services and be the QA main contact with clients for the related projects
Ensure appropriate contacts and relationships with monitoring authorities
Audits and Inspections
Perform Independent review of Documents (plans, protocols, reports, regulatory docs, etc.)
Perform internal audits (processes, systems)
Perform qualification audits and periodic quality audits of suppliers and sub-contractors
Write audit reports, recommend corrective actions as applicable and ensure appropriate follow-up
Perform a peer-review of audits reports written by others
Contribute to building the internal and external audit program
Immediately inform the site Head of QA and other concerned managers, and specifically the Chief Pharmacist officer (Qualified person), of any major issue or non-compliance
Quality Management
Under the responsibility of the Head of QA:
Ensure worldwide regulatory and standard intelligence in the areas of quality and compliance
Define GMP/GDP standards for quality training to ensure the implementation of quality strategy and policies
Contribute to the readiness of the site for GMP inspection by Health Authorities and customer audits
Provide Quality Management support and expertise to the Operations
Contribute to the implementation and follow-up of quality management system
Pilot / accompany process optimization activities
Contribute to implementing and exploiting quality approach tools and audit results corrective actions
Contribute to the update of Quality Assurance SOPs
Provide regulatory text interpretation and impact analysis
Contribute to collect data and prepare QA activity KPI (Key Performance Indicators)
QUALIFICATIONS
Doctorate in Pharmacy
At least 5 years’ experience in Quality Assurance
Pharmacist registered in the section B of the CNOP (Conseil de l’Ordre des Pharmaciens)
Knowledge of GMP standards
Knowledge in biological products development ( manufacturing, quality control ) would be highly appreciated
MUST HAVE
You are autonomous, organized, rigorous, versatile and easily adaptable to a fastpaced environment with good communication and written skills. Your teamwork skills are recognized and you take initiatives.
Fluency in French and English, both written and spoken, is required.