OBJECTIVE:

In charge of: Quality Assurance aspects in the CMC Generic R&D and in the Clinical Supply (if applicable). Reports to Associate Director Quality Assurance R&D.

JOB CONTENT & RESPONSIBILITIES:

  • Primary R&D Quality function and subject matter expert for Generic R&D Quality Assurance at the Haarlem Site
  • Collect and communicate appropriate metrics and participate in Site R&D Quality Council meetings
  • Serve as the primary interface with Generic R&D QA from other sites.
  • Member of the Generic CMC forum. Takes part in the CMC decision making in issues related to Quality Assurance
  • Accompanies external audits as required and provides all relevant data. Ensures the implementation of corrective actions resulting from the inspections
  • Approves all Generic R&D documents (i.e Formula and production methods, Validation Protocols and Reports, Standard Operating Procedures, Work Instructions, Operating Instructions and relevant forms for the Generic R&D and the Clinical Supply Unit
  • Supervises quality assurance activities of the Generic R&D team and the clinical supply unit relating to manufacturing of clinical batches and packaging of clinical supplies for clinical studies, and ensures compliance with cGMP guidelines, Teva Standard Operating Procedures and national and international laws applicable in the relevant countries
  • Ensures that there is a review of ongoing stability data for trends and for support of proposed product shelf life as data becomes available, for submission batches.
  • Ensures that there is a program for approval and monitoring of contract manufacturers and contract facilities for Generic R&D and Clinical Supply Unit activities
  • Performs internal audits in the Generic R&D and the Quality Control Laboratories, according to an annual audit program. Ensures that corrective actions are implemented and effective
  • QA representative for Technical Transfer between Generic R&D and Operations

JOB REQUIREMENTS:

  • MSc in pharmacy / chemistry/ biotechnology or BSc in pharmacy / chemistry/ biotechnology with experience in QA R&D
  • Quality Assurance Experience in Generic R&D manufacturing site
  • GMP, GLP and GCP Auditing experience
  • Intensive training in cGMP
  • Experience in R&D pharmaceutical development manufacturing and control
  • Familiarity with industry-standards
  • Challenge the status quo
  • Experience owning a defined portion of a project, and a demonstrated ability to manage issues and risks, with an understanding of appropriate and timely escalation..
  • Excellent “client” facing communication (written and oral) and interpersonal skills
  • Proven ability to work creatively and think analytically
  • Ability to manage own time
  • Integrity
  • Fluent English and Dutch

YOUR INTEREST

For this challenging varied position within Teva Pharmachemie, we offer an attractive salary as well as good benefits within a dynamic, international working environment.

YOUR APPLICATION

In case you are interested in this vacancy, fill in the application form.

For information about this vacancy you can directly contact the responsible manager of the department, Mrs Catherine Massé on 023-5 147 261.