Validation Expert Analytical Lab

  • Location: Heist op den Berg
  • Type: Contracting
  • Job #19947

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Validation Expert Analytical Lab

Location: Heist-op-den-Berg

Scope of work:

  • Validation of analytical methods & method transfer
    • Set up and write validation protocols
    • Analyze the validation results
    • Provide conclusions
    • 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 enquiries
  • 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

Who are you?

  • Master’s or bachelor’s 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 ability to work independently and to work in global cross-functional project teams.
  • Proactive attitude, taking 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 for innovation and proposal of new ideas. Have good creativity 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 the Dutch and English languages

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

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