Quality Assurance Specialist

vor 3 Wochen

Munich, Bayern, Deutschland SciPro Vollzeit
Job Title: Quality Control Specialist

Job Summary:

SciPro is seeking a highly skilled Quality Control Specialist to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring that all pharmaceutical products meet the highest quality standards and comply with industry regulations.

Key Responsibilities:

  • Performing Quality Control Testing: Conduct routine and non-routine tests on raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with internal and regulatory standards.
  • Documentation and Reporting: Accurately document all test results, ensuring compliance with GMP guidelines and internal protocols. Maintain and review QC records, logs, and reports.
  • Method Validation: Assist in the validation of analytical methods to ensure accurate, reliable, and repeatable results. Collaborate with R&D to develop and refine QC methods.
  • Equipment Calibration and Maintenance: Perform routine calibration, troubleshooting, and maintenance of laboratory instruments and equipment. Ensure that all instruments are functioning correctly and properly maintained.
  • Compliance and Audit Support: Ensure compliance with all internal SOPs, GMP, and regulatory requirements. Support audits (internal and external), providing documentation and information as required.
  • Root Cause Analysis and CAPA: Investigate deviations, OOS (Out of Specification) results, and complaints to identify root causes. Implement corrective and preventive actions (CAPA) to mitigate future risks.
  • Cross-Departmental Collaboration: Work closely with production, quality assurance (QA), and regulatory teams to ensure seamless product release and compliance with all quality standards.
  • Continuous Improvement: Proactively seek and recommend improvements to QC processes and protocols to enhance efficiency, accuracy, and product quality.

Qualifications and Skills:

  • Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
  • 3+ years of experience in a QC role within the pharmaceutical industry.
  • Strong knowledge of GMP, GLP, and regulatory standards (e.g., FDA, EMA).
  • Proficiency in analytical techniques such as HPLC, GC, FTIR, and UV/Vis spectroscopy.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication skills, both written and verbal.
  • Ability to work independently and as part of a team.
  • Proficient in Microsoft Office Suite and LIMS (Laboratory Information Management System).
  • Fluency in German and English is required.

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