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DEPUTY QUALIFIED PERSON / QUALITY ASSURANCE ASSOCIATE (Start Date: Q4 2017) - JOB076

Updated on 05 Sep 2017

Job description

As a Qualified Person in the Compliance Department team, you will assist and deputise for the regular Qualified Person in the following duties:
  • Approval of reports and certificates of analysis, GMP contracts, deviations and change requests
  • Management of analytical methods, outsourcing and importation of clinical batches, in compliance with applicable procedures
  • Verification of procedures on the management of deviations, change requests, samples, technical procedures, reagents and products, training, methods, specifications, outsourcing and importation of clinical batches
As a Quality Assurance Associate, you will have (or participate in) the following tasks and
responsibilities:
  • Managing Standard Operating Procedures
  • Training personnel in procedures and the Quality System
  • Maintaining and developing the Quality System
  • Updating the Site Master File
  • Monitoring Key Quality Indicators and Key Performance Indicators
  • Promoting risk management and continuous improvement strategies
  • Drawing up the Quality Management Review (QMR)
  • Managing CAPAs
  • Carrying out and following up client and regulatory agency audits
  • Carrying out internal audits of facilities, processes and projects
  • Assessing quality contracts provided by clients
  • Monitoring quality in client projects
  • Advising clients on subjects related to quality
  • Qualifying providers

Education and professional qualifications

Master’s degree in Industrial Pharmacy, registered as a QP in Belgium

Skills

Technical skills

Required

Theoretical knowledge of physicochemical and molecular and cell biology analytical techniques

General skills

Requires

  • Good knowledge of the pharmaceutical sector, Quality Assurance principles, GMP and ICH guidelines
  • Francophone, with a good knowledge of English, both written and spoken

Experience

Required

At least 2 years’ experience in a similar position

In addition to the fringe benefits received by all the personnel, you will also be provided with a company car.

How can you apply?

Send your application now, for the attention of Mr Bernard Adant, Talent Acquisition Manager, to

recrutement@quality-assistance.be

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