QC Senior Technician Chemistry Amsterdam • Prothya Biosolutions

Key responsibilities:

• Perform 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.

Other responsibilities:

Legal compliance:

• Stay current on evolving legal requirements related to pharmaceutical manufacturing.
• Ensure the organization's compliance with applicable laws, regulations, and industry standards.

Environmental health and safety (EHS) compliance

• Adhere to EHS policies and practices within QC.
• Adhere to all safety protocols and regulations in the laboratory environment, including proper handling, disposal, and containment of microbiological hazards and biohazardous waste.
• Supports measures to ensure a safe and environmentally responsible workplace within QC.

Your profile:

• Secondary laboratory education, (K)MLO or related field.
• Experience working in a pharmaceutical laboratory, preferably in a GMP-regulated environment.
• Knowledge of chemical testing techniques, spectroscopy, titrations and various assays.
• Proficiency in data analysis and interpretation using laboratory software applications (e.g., SAP).
• 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.

What We Offer:

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking options available.
• Pension plan with Zorg & Welzijn.

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.