Quality Assurance Associate GMP / Pharmacist (f/m)

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.