QC Analyst Microbiology  Amsterdam • Prothya Biosolutions

The Pharmaceutical Quality Control (QC) Analyst - Microbiology plays a critical role in ensuring compliance of pharmaceutical products and raw materials. This analyst is responsible for performing a variety of microbiological tests and analyses in accordance with regulatory requirements, Good Manufacturing Practice (GMP) guidelines and internal quality standards. The QC Analyst will work collaboratively with cross-functional teams to support product release, investigations and continuous improvement initiatives within the QC laboratory.

Key responsibilities:

• Perform routine and non-routine microbiological testing of raw materials, in-process samples and finished products samples using approved test methods and protocols.
• Document all microbiological testing activities, including test results, observations, deviations, and corrective actions, in compliance with Good Documentation Practices (GDP) and GMP regulations.
• Interpret microbiological data and results, promptly reporting any deviations or outof-specification (OOS) findings to management and assist in investigations and root cause analyses as needed.
• Participate in the qualification, calibration and maintenance of microbiological testing equipment and instrumentation, ensuring accuracy, reliability, and compliance with regulatory standards.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Production, to support product release and investigations.
• Assist in the development, optimization and validation of microbiological testing, methods and procedures to ensure robustness, accuracy and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
• Assist in the investigation and resolution of laboratory deviations, nonconformances and customer complaints, following established Corrective and Preventive Action (CAPA) procedures.
• Receive and log incoming samples, verifying documentation for accuracy and completeness.

Your profile:

• MLO or Bachelor’s degree in chemistry, pharmaceutical sciences, or a related field.
• >3 years of experience working in a pharmaceutical laboratory, preferably in a GMP-regulated environment.
• Strong knowledge of microbiological testing techniques
• Proficiency in data analysis and interpretation using laboratory software applications (e.g., SAP and Empower).
• Excellent attention to detail, organizational skills, and ability to work effectively in a regulated environment.
• Strong communication skills and ability to collaborate with cross-functional teams.
• High level of independence is required when carrying out work according to guidelines, procedures and protocols.
• Perseverance and patience are required during routine analysis and the collection of data for deviations.
• Accurate, structured, flexible, and quality and safety conscious.
• You are able to work under time pressure and you can organize and plan your work independently.
• Good command of the English language is required, and at least a basic understanding of Dutch.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.