Pharmacien Assurance Qualité H/F en CDD/Mission 5 mois
CDD Issy-les-Moulineaux (Hauts-de-Seine) Conception / Génie civil / Génie industriel
Description de l'offre
Supervision
Under supervision of the Quality Assurance Manager
Overall responsibilities:
· In accordance with internal SOPs, local and EU legislation, to perform quality activities for our products in support of the QA Experts.
Quality Support & Quality Product Management:
· Providing administrative support for Quality Assurance Team to support high levels of team efficiency.
· Providing QA support to internal Janssen customers and maintaining high levels of internal customer service.
· Product Quality Complaint Reporting
· Performing PQR (Product Quality Review)
· Participation in the Site Master File redaction
Quality Assurance processes & Compliance
· Managing the process for handling non-conformances, including temperature excursions.
· Ensuring all external contractors/suppliers relevant to GMP/GDP are appropriately managed
· Ensuring a robust quality system is in place throughout the supply chain, at third party warehouse and within the company, to ensure compliance with GDP.
· Update SOPs in relation with their activity
Profil recherché
Skills and capabilities:
· Quality Assurance experience at operational level or other relevant experience including Quality Compliance.
· Direct experience and sound knowledge of general quality requirements and guidelines/legislation.
· Self-identify relevant information and actions and prioritise workload
· Excellent interpersonal, collaboration and verbal and written communication skills, self-motivated, clear thinker and organised.
· Ability to communicate with internal and external customers
· Ability to identify ways of streamline processes and take initiative in suggesting new approaches in order to drive continuous improvement
· Ability to work to deadlines in order to work to compliance metrics
· Very good knowledge of English, verbal and written
· Multitasking, accurate and conscientious
Internal and external contacts:
· All departments interacting with QA: RA, PV, supply chain, commercial, legal, medical info…
· Internal & External manufacturing sites
· External Suppliers or service Providers
· All customers
Experience:
Pharmacist: 0-3 years' experience, beginner to QA.
Previous experience in QA role or similar role is of advantage (master in Quality Assurance).