Qa Auditor For Cmo And Pharma Supply

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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