(Senior) Scientific Associate in ADQC

vor 3 Wochen


Basel, Schweiz CK Science Vollzeit

(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. 

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