Validation Expert Analytical Lab

For a client in the province of Antwerp (East), we are looking for a Validation Expert Analytical Lab.

  • Do you have two years experience in an analytical lab?
  • Are you familiar with HPLC?
  • Do you know the GMP regulations?
  • Do you have a scientific degree?

Do you see a fit with your profile and these questions? Then this project might be just right for you!

Job Description 

Validation of analytical methods & method transfer: need to be able to set up and write a validation protocol, to analyze the validation results, provide conclusion and write validation report 

  • Cleaning Validation: Sample preparation, HPLC analysis, processing of HPLC data with Empower software
  • Compendial review: Assess compendial changes, perform method verification, training of analysts
  • Annual review (reduced testing program): Data analysis + reporting
  • Response to internal & external inquiries
  • Review data generated by other analysts of the team
  • Develop and/or review departmental documentation including lab data sheets, training documentation, SOP's, change controls, deviations and CAPA (Corrective Action/Preventive Action) ensuring compliance with GMP and applicable regulatory guidelines.
  • Provide analytical technical expertise in pharmacopeia tests, regulatory requirements, changes, and investigations, root cause analysis
  • Share successes with other departments during report out session with management
  • Organize and lead method transfer project meetings, attend conference calls
  • Attend daily communication
  • Work according to applicable safety guidelines 
  • Masters or bachelor degree in chemistry/sciences/pharmaceutics or equivalent by experience.
  • A minimum of 2 years’ experience in an Analytical Lab.
  • Experience in the creation of validation protocols, SOP’s, and preparation of validation reports.
  • Experience with HPLC (experience on Waters system is a plus)
  • Knowledge of Pharmacopeias (USP, Ph. Eur., JP)
  • Working knowledge of cGMP requirements.
  • Good verbal and written communication skills.
  • Ability to work precisely and accurately.
  • Team player with the ability to work independently and to work in global cross-functional project teams.
  • Proactive attitude, taking the initiative to help drive the projects forward.
  • Strong organizational skills and demonstrated ability to manage projects to completion are highly desired.
  • Strong demonstration of problem-solving skills. Open to innovation and proposal of new ideas. Have good creative thinking skills.
  • Ability to understand and extract necessary information from technical documents.
  • Ability to effectively manage workload and prioritize activities. Ability to handle multiple tasks simultaneously and to meet critical milestones and goals.
  • Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint.
  • Good knowledge of Dutch and English
Contact Information 

Anneleen De Vos
015 21 11 04

Application form : Validation Expert Analytical Lab

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