Quality Assurance Officer - M/F (M/F)
Medipha Santé, a company founded in 2004, is a French pharmaceutical laboratory located in Villebon-sur-Yvette (Z.A. de Courtabœuf - 91) holding the status of operator and establishment responsible for batch certification, offering other national or international pharmaceutical laboratories a wide range of services in the health field (https://www.medipha-sante.fr/).
Medipha Santé is looking for a/an
Quality Assurance Officer M/F
available as soon as possible.
Reporting to the Pharmacien Responsable/EU-QPPV, you will organize and provide support to other collaborators in the quality assurance department on various quality assurance missions for the laboratory itself and as a service provider for other companies bound by contract. Thus, you will specifically take charge of the following activities:
- monitoring of QA contracts with various partners (manufacturers, subcontractors)
- Design, writing, and monitoring of procedures and documents of the QA system
- Planning and monitoring of internal and external audits
- Writing of audit reports
- Management of customer complaints
- Management of deviations
- Management of Change control
- Management of corrective and preventive actions (CAPA)
- Preparation and conducting of internal training
- Participation in the management of medical information requests
- Review of batch records
- Participation in batch recalls
- Answering questions from authorities regarding QA
- Regulatory monitoring for QA
- Review and validation of packaging articles
- Audits and self-inspections
- Review of product quality reviews
We are looking for a candidate with a successful first experience of at least 1 or 2 years in similar missions/positions.
Strong adaptability and teamwork skills, good technical knowledge, agility, concern for quality, and respect for deadlines are essential qualities for this position.
A good level of written English is imperative, and spoken English would be a highly appreciated plus.
If you are interested in joining a dynamic team within a growing but human-sized laboratory, please send your CV and cover letter to the following email address: recrutement@medipha.eu, specifying your availability date.