Quality Assurance Specialist

• Establishing, maintaining and improving the Quality Management System in accordance with GMP requirements.
• Overseeing the quality documentation system.
• Developing, updating and overseeing quality documentation and SOPs.
• Approving and overseeing the change control process.
• Participating in validation processes and overseeing validation documentation.
• Contributing to the implementation of quality risk assessment methods.
• Preparing risk analyses and participating in investigations into deviations and CAPA.
• Conducting Product Quality Reviews (APR/PQR) and overseeing their timely completion.
• Overseeing the qualification of suppliers, manufacturers and contractors.
• Ensuring that the required tests are carried out at all stages of production and on finished products.
• Approving specifications, sampling instructions, test methods and quality control procedures.
• Monitoring quality indicators (KPIs) and initiating improvement measures.
• Preparing the manufacturing site for audits and inspections, and actively participating in client audits and inspections by external bodies (GIF, certification audits and others).
• Preparing reports, documentation and responses following audits and inspections.
• Responsibility for achieving quality objectives.
• Keeping up to date with pharmaceutical legislation and GMP requirements.

• A relevant university degree in pharmacy, chemistry, microbiology or a related field.
• At least 2 years’ experience in quality assurance (QA) at a pharmaceutical or radiopharmaceutical company operating in accordance with GMP requirements.
• Knowledge of GMP requirements and pharmaceutical legislation.
• Experience in validation, change control, risk management and CAPA.
• Analytical thinking and problem-solving skills.
• Analytical thinking and problem-solving skills.
• Fluency in English.

You are welcome

• Experience in preparing and conducting audits and inspections.

• Stable employment based on an employment contract.
• Work in an environment with high quality standards in line with GMP.
• Support for professional development through participation in internal and external training courses.
• A real influence on the operation and development of the Quality Management System.
• Work in a modern office.
• Collaboration with an experienced team of experts from the radiopharmaceutical industry.
• A friendly working atmosphere.

Please submit your application, including your CV, via the form below.

We reserve the right to contact selected candidates only.