Pharmacien Assurance Qualité H/F en CDD/Mission 5 mois

  • Par Johnson And Johnson
  • CDD
  • Issy-les-Moulineaux (Hauts-de-Seine)
  • Qualité / Sécurité / Hygiène
2016-10-05T05:51:15+0200

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).

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