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Product Support Specialist - 12 months

Belgium, Belgium

  • Salary: £40 - £55 per hour
  • Job type: Interim/Contract
  • Posted: 08/12/2017
  • Contact name: Frankie Cunningham
  • Contact number: 01892 612612
  • Ref: 2830

Job description

This position will provide QA expertise in product related project activities concerning our client's products that are externally manufactured.

Be part of a proactive, solution oriented operational QA team and projects teams that will drive quality related project activities for lifecycle management of Vendors (Contract Manufacturing Organizations) and the associate Products portfolio.

This position will provide Quality support in particular in relation to:

  • Regulatory Submissions and related coordination activities
  • Product Quality Evaluations
  • Product related documents
  • Product cockpits
  • Product metrics
  • Product chain overview and maintenance of flows (in accordance with Eudralex Annex 16)
  • Product related project support
  • Product change controls
  • Product market complaints metrics and analysis

Role related accountabilities:

  • Provide support to the Global (Product) Quality Leads with respect to Quality support on e.g.,
  • Support Regulatory Submissions and coordinate related activities (e.g., inspection presentation,  collection stakeholder input for responses to agency)
  • Product Quality Evaluations
  • Prepare, manage, distribute Product related documents
  • Maintain Product cockpits and data
  • Collect, analyse and report Product metrics including Trackwise metrics
  • Maintain Product chain overview and prepare / maintain of flows (in accordance with Eudralex Annex 16)
  • Product related project support
  • Support preparation of PQR Executive summary reports, tracking of individual PQRs, link with QC, data extraction, etc.
  • Prepare Product change control committees; organize change control follow-up and tracking, ensure follow up of regulatory approvals and closure of action items
  • Prepare Product market complaints committees; collect and analyse complaint metrics and prepare for meetings, maintenance Cimzia appendix/link with statisticians for revision of control limits
  • Product stability program
  • Product risk review
  • Preparation of inspections (at CMOs or internal UCB sites)
  • Coordination of regulatory request across sites
  • Maintenance of team SOPs
  • Preparation of management review

Required Experience:

  • 4-8 years working in the pharmaceutical biologics/sterile industry with a profound knowledge and understanding of Quality management and operational GMP experience
  • Experience interacting with regulatory bodies and third party organizations with respect to QA systems and regulatory inspection preparedness. 

Specific skills

  • Experience and knowledge about European and US Good Manufacturing Practices
  • Good pharmaceutical technical understanding and expertise enabling to review and judge upon technical documents related to manufacturing and analytical testing
  • A QA critical mind set on reviewing documents
  • Fluent and confident use of English language verbally and in writing
  • Good knowledge of reading & understanding of French is a plus as some documents may be written in French
  • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
  • Ability to work autonomously for the assigned project activities with limited oversight by UCB leader
  • Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
  • Must be skilled and experienced in operating across cultures and in a multi-cultural environment
  • Project management experience is nice to have
  • Ability to extract data from Trackwise system and further data handling in Excel
  • Ability to prepare Powerpoint presentations

If this role is of interest please make an application by either using the form below or you can contact me directly on 01892 612 612 frankie.cunningham@hobsonprior.com