QC Senior Analyst Chemistry Amsterdam • Prothya Biosolutions

Key responsibilities:

• Perform routine and non-routine chemical testing of raw materials, in-process samples and finished products samples using approved test methods and protocols.
• Document all chemical testing activities, including test results, observations, deviations, and corrective actions, in compliance with Good Documentation Practices (GDP) and GMP regulations.
• Interpret chemical data and results, promptly reporting any deviations or out-of-specification (OOS) findings to management and assist in investigations and root cause analyses as needed.
• Participate in the qualification, calibration, and maintenance of chemical testing equipment and instrumentation, ensuring accuracy, reliability, and compliance with regulatory standards.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Regulatory Affairs, to support product release, investigations, and regulatory submissions.
• Assist in the development, optimization, and validation of chemical 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, non-conformances, and customer complaints, following established Corrective and Preventive Action (CAPA) procedures.
• Entails meticulous planning of laboratory activities, ensuring samples are processed within due timelines, and providing oversight of lab operations.
• Provide technical guidance, training and support to junior technicians and laboratory staff.
• Assist the supervisor in daily operations, including scheduling and recruitment.
• Stay updated on industry trends, developments, and best practices in chemistry and pharmaceutical sciences.
• Adhere to environment health and safety policies and practices within QC.

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 chemical testing techniques, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet-Visible (UV-Vis) spectroscopy, and Fourier Transform Infrared (FTIR) spectroscopy.
• 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.
• Hands-on problem-solving skills – translating your understanding of the problem into an approach towards a solution.

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.