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(Senior) Scientific Associate in ADQC

Website Achieva Group Limited

Our client is looking for a Scientific Associate in ADQC, working on site at their offices in Basel.

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.

The Scientific Associate working in AD/QC will have the following responsibilities and
tasks which are
related to the company site Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland:
• 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

REQUIRED QUALIFICATIONS AND EXPERIENCE
• Apprenticeship-, College-, or university-degree or equivalent education in the
field of chemistry, biology, biochemistry, pharmacy, or chemical engineering,
apprenticeship 6-10 years, 4-8 years BS or 3-5 years
• MS experience. Ability to efficiently plan, execute and document analytical
experiments in a GMPcompliant 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.
• 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.

Must have:
HPLC experience
GMP experience
Experience in dissolution testing
Empower software experience

If you would like to know more information about this role please contact Marta on +44 17 27 817 600 or email to mcintra@achieva.co.uk

Upload your CV/resume or any other relevant file. Max. file size: 128 MB.

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