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Quality Specialist – Pharmaceutical QC

EPM Scientific · Sarre

جديد
🇬🇧 English
HPLC GC UV/VIS Laboratory information systems MS Office

وصف الوظيفة

About the role

We are looking for a Quality Specialist to join the Quality Control team at a pharmaceutical production site in Saarland. The role supports GMP‑compliant release of raw materials, intermediates and finished products and contributes to continuous improvement of analytical processes.

Key responsibilities

  • Support GMP‑based approval of raw materials, intermediates and finished products by reviewing analytical data.
  • Evaluate and interpret laboratory test results against specifications and quality standards.
  • Oversee laboratory activities to ensure compliance with GMP regulations and internal procedures.
  • Perform independent checks of analytical data for accuracy and consistency.
  • Investigate out‑of‑specification results, identify root causes and implement corrective and preventive actions.
  • Identify and drive process improvements, including the introduction of new analytical techniques or systems.
  • Draft, update and maintain SOPs in line with regulatory requirements.
  • Assist in internal and external audits and follow‑up on audit actions.
  • Document and report all QC activities according to GMP standards.
  • Provide training and guidance to laboratory staff and support onboarding of new methods and technologies.

Required profile

  • Degree in Pharmacy or equivalent qualification meeting §15 AMG requirements.
  • Initial experience in pharmaceutical quality control within a GMP‑regulated environment.
  • Strong understanding of GMP, ICH guidelines and regulatory expectations.
  • Analytical mindset with high precision in handling test results and deviations.
  • Fluent German (C1) and good English (B1 or higher).

Required skills

  • HPLC
  • GC
  • UV/VIS
  • Laboratory information systems
  • MS Office

What we offer

  • Stable position within an international, quality‑focused environment.
  • Opportunities for professional development and career growth.
  • Collaborative and inclusive working culture.
  • Exposure to modern pharmaceutical production and quality systems.

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EPM Scientific

Sarre