Quality Assurance Officer for Shopfloor Operations

3 weken geleden

Amsterdam, Noord-Holland, Nederland Prothya Biosolutions Voltijd

Job Title: Quality Assurance Officer for Shopfloor Operations

The Quality Assurance Officer for Shopfloor Operations at Prothya Biosolutions is responsible for ensuring manufacturing compliance with applicable procedures and batch records. This role involves providing real-time review of manufacturing batch record documentation and logbooks, as well as working with operations to resolve manufacturing issues.

Your Responsibilities

  • Perform QA shopfloor activities.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Perform real-time review of manufacturing batch records.
  • Review manufacturing shopfloor documentation.
  • Must be skilled in planning, organizing, and decision-making.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Your Profile

  • BSc degree or above in a relevant field (pharmaceutical, chemistry, biology...)
  • Minimum 5 years of relevant work experience, with at least three years in a Quality Assurance role or equivalent combination of education and experience acceptable.
  • Action-oriented and skilled in decision-making, planning, and organizing, coaching others, and analytical thinking.
  • Sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments. Preferably with knowledge of GMP Manufacturing operations and processes.
  • Aseptic filling knowledge is an advantage.
  • Ability to recognize and resolve Quality issues, inform management of proposed solutions, and seek management guidance on complex issues.
  • Confident in making decisions for non-routine issues in agreement with management.
  • Develop and revise procedures.
  • Prepare written communications and communicate problems to management with clarity and accuracy.
  • Knowledge of global cGMP requirements.
  • Adaptable and focused on quality matters.
  • English is a must; Dutch is an advantage.

Our Offer

  • Full-time employment.
  • 8.33% end-of-year bonus and 8.33% holiday allowance.
  • Flexible working hours in consultation.
  • Personal training budget of €2,000 per 3 years.
  • Contribution to travel expenses from the first kilometer.
  • Good accessibility by public transport and private parking.
  • Pension plan at Zorg & Welzijn.

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