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Validation Expert Analytical Lab

Published on Jobat.be 46 days ago

Validation Expert Analytical Lab

Job description

As a validation expert, you are responsible for: 
  • 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 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

Profile

As a validation expert, you possess following qualities: 
  • Master's 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, SOPs, 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.

Offer

  • Challenging projects based on your interests and skills

  • Personal follow-up and clear, transparent communication both before and after commencement of employment

  • Possibility to follow extra training

  • Inspiring network events and legendary after work drinks

  • Strong network of industry leading clients

  • Expertise within IT, Engineering and Life Sciences

  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

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Pauwels Consulting | Heist-op-den-Berg 2220

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    14 days left to apply

    Characteristics

    Requirements

    • Master (University or Higher Education Long Type)
    • Dutch

    Offer

    • Permanent
    • Independent
    • Full-time
    • Company car

    Apply before

    • 16 June

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