QA GMP Specialist – Biological Products

QA GMP Specialist – Biological Products

ProductLife Group

Braine-l'Alleud, Belgium

As a result of the deployment of our activity a new project we are now seeking a Quality Assurance Specialist Biological products.

You will provide advice and support on operational and general QA activities to our client teams working on Drug Substance and Drug Product development, Technology transfer, manufacture and submission preparation.

Primary Responsibilities

  • Review and approval of project documentation, such as:
    • Technology Transfer protocols and Reports;
    • Manufacture and analytical testing, process development studies (including holding times, filter validation, impurities clearance etc.), aanalytical validation studies according to ICH Q2; stability studies, protein characterisation, mammalian working cell banks (preparation, testing, characterization), review of completed CMO batch documentation;
    • Deviations, Change controls, CAPA.
  • Such review will include:
    • Check of referenced documents and data;
    • Compliance with relevant protocol, SOP, GMP guideline, or regulatory guidelines;
    • Deviations and changes are properly addressed and documented;
    • Consistency with other documents;
    • Discussions and conclusions are pertinent and consistent with data;
    • Comments from review are correctly addressed;
    • Review and approve analytical, DS and DP CMC submission sections.
  • Such review will include:
    • Consistency with supportive documents and other sections;
    • Comments from review are correctly addressed;
    • Content is in line with relevant regulatory guideline.

Candidate Profile.

Education:

  • Bachelor’s degree.

Experience:

  • Minimum of 5 years working in the pharmaceutical biologics industry in a quality assurance position.

Key Skills

  • Operational GMP experience would be a distinct advantage;
  • Good knowledge in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations together with quality principles and techniques;
  • Experience with DS and/or DP process manufacture for biological products;
  • Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the business;
  • Good knowledge of regulatory submission preparation for biological products;
  • ICH Q2 analytical method validation principles and general analytical techniques;
  • Understands practical applications of GMP, compliance principles and theories including risk management;
  • To be able to ensures free flow of information to the appropriate stakeholders;
  • Fluent in written and spoken English and Dutch and/or French.

Core Competences

  • You can demonstrate initiative and an ability to help team and others solve problems creatively and practically;
  • Ability to identify risks and to propose corrective actions in complex situations;
  • Taking innovative approach to working practices.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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