Qa Auditor For Cmo And Pharma Supply

vor 1 Woche


Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

Randstad is looking for an Analytical Chemistry Specialist with experience in peptides and drug substance analytics. If you have a strong technical background in this area and want to work for a leading company in the sector, this opportunity is for you.

Responsibilities:

  • Conduct analysis and characterization of peptides using various analytical techniques.
  • Ensure that all critical analytical parameters for peptides — such as purity, identity, and content — are properly defined and validated.
  • Confirm the use of appropriate, validated methods for batch verification, including HPLC, LC-MS, and NMR.
  • Oversee stability studies according to ICH guidelines to ensure the peptide maintains integrity in its solid form.
  • Set and maintain acceptance criteria for release testing, aligned with regulatory and internal quality standards.
  • Review and approve the CMO's manufacturing processes, including:

Drying and solidification techniques (e.g., lyophilization).

Storage conditions (temperature, humidity, packaging).

Use of excipients, if applicable.

  • Define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) relevant to solid-state peptides — such as residual solvents, moisture content, and solid form stability.
  • Ensure appropriate controls are in place to detect impurities or degradation, such as aggregation, oxidation, deamidation, and racemization.
  • Review and approve the analytical methods used by the CMO to ensure they meet regulatory and scientific standards.
  • Oversee identity testing (to confirm correct amino acid sequence) and impurity profiling.
  • Ensure that all testing and controls at the CMO are performed under GMP-compliant conditions.
  • Participate in batch record review and deviation management, including the evaluation of borderline or out-of-specification results.
  • Monitor ongoing trend analysis to identify potential quality or process issues early.

Requirements:

  • 5 to 10 years of experience in analytical chemistry applied to peptides.
  • Proficiency in analytical techniques for peptides, including HPLC, LC-MS, CE, CD Spectrometry, and NMR Spectroscopy.
  • Experience in method development and validation.
  • Familiarity with GMP regulations and pharmaceutical compliance standards.
  • Advanced English proficiency (mandatory), German knowledge is a plus.
  • Ability to work in a team and in a highly regulated environment.

Benefits:

  • Opportunity to work in a leading pharmaceutical company.
  • Professional development in an international environment.
  • Competitive salary and attractive benefits package.

If you meet the requirements and are interested in this position, please send your updated CV.

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