Scientific Associate in ADQC - Basel, Schweiz - CK Science

    CK Science
    CK Science Basel, Schweiz

    vor 2 Wochen

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    Beschreibung

    (Senior) Scientific Associate in ADQC

    QLS are recruiting for a Scientific Associate in Analytical development and QC to join an innovative pharmaceutical company based in Basel on a contract basis for one year

    Analytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.

    RESPONSIBILITIES AND TASKS:

  • Development, optimization and application of analytical methods, e.g., for purity-, stability-, content-and potentially genotoxic impurity determinations.
  • Write-up of analytical methods for implementation.
  • Conduct of release, retest, stability studies, transfer and validation analyses.
  • Proper documentation of all analytical activities according to Good Documentation Practices.
  • Interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
  • Write-up of analytical protocols and reports, e.g., for validation and stability studies.
  • Assurance of adequate maintenance and operation of analytical equipment according to GMP.
  • Drafting and review of CoAs and/or Analytical results sheet.
  • Drafting of SOPs, GUIs, TPLs, FRMs.
  • Training of Laboratory personnel.
  • Ensuring of cleanliness of laboratory and work space.
  • Independently designs and executes projects or experiments with hands on involvement.
  • Independently reviews scientific work in project related activities.
  • Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment.
    • REQUIRED QUALIFICATIONS AND EXPERIENCE:
  • Apprenticeship, College or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering, with 3 - 5 years experience.
  • MS experience. Ability to efficiently plan, execute and document analytical experiments in a GMP compliant pharmaceutical environment.
  • Good knowledge of analytical chemistry with advanced knowledge of sample preparation, HPLC and spectroscopic instrumentation.
  • Good troubleshooting skills for analytical analyses. Good knowledge of GMP. High flexibility, advanced communication, time-management and team-working skills.
  • Experience in dissolution testing is a must.
  • Good knowledge of Empower software.
  • Ability to work independently and to take initiative. Life-long learning mindset and strong sense of accountability.
  • Should actively seek for technical solutions to improve quality and productivity.
  • Proficient in English.