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Job ID :
64969BR
Location :
Netherlands - Tilburg
:
Job Description
The Analytical Development (AD) Chemist is responsible for conducting analytical work within the Analytical Development Department R&D. You are conducting analytical work for analytical R&D projects according GMP/GLP and ICH guidelines by:
  • Collecting samples, label packs, put/pull samples in stability chambers following the protocols;
  • Conducting stability studies according ICH guidelines;
  • Conducting physical and chemical analysis with HPLC, GC, UV/VIS, FTIR, Karl-Fisher, Dissolution and Disintegration instruments;
  • Developing and validation of analytical methods;
  • Transferring analytical methods to QC or to other Patheon companies;
  • Conducting cleaning validations and conduct analysis of cleaning validation samples;
  • Trouble shooting at QC lab for release of new nutritional and pharmaceutical products;
  • Assisting the QA validation department with performing cleaning validation programs;
  • Overseeing and coordinating activities at contract Laboratories;
  • Coordinating stock for chemicals/consumables;
  • Writing analytical activities in lab note books;
  • Conforming GMP/GLP guidelines;
  • Performing double checks of all analytical results;
  • Writing analytical stability protocols and reports;
  • Writing analytical validation protocols and reports;
  • Establishing, revising and enforcing laboratory policies and procedures, which are relevant for the analytical R&D department;
  • Keeping up to date with current regulatory requirements (ICH/FDA) guidelines and GLP/GMP guidelines) and pharmacopoeia requirements (EP/USP) with respect to method validation and stability studies;
  • Double checking of analytical test result in lab note books and stability data sheets;
  • Performing investigations and writing failure report for out of specification (OOS) test results and document findings;
  • Exchanging information within R&D, QC, QA and Operations (internally meetings/e-mails);
  • Keeping up to date with development in Analytical Technologies.

Qualifications
  • Education in chemistry or Analytical chemistry HBO+.
  • A minimum of 5 years’ experience not only in pharmaceutical, but method development and validation as well.
  • Good skills to conduct accurate chemical analysis with analytical equipment.
  • Strong technical knowledge in the analytical chemistry.
  • Excellent reporting capability.
  • A good working knowledge of oral and written English.
  • Current knowledge of GLP/GMP and ICH/FDA requirements and Pharmacopeia (EP/USP) requirements for analytical development and stability studies.


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