Quality Specialist – Pharmaceutical QC
EPM Scientific · Sarre
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
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