Quality Assurance Officer Shopfloor Operations

1 maand geleden

Amsterdam, Noord-Holland, Nederland Prothya Biosolutions Voltijd

The Shopfloor Quality Assurance Officer is responsible for ensuring quality activities at Prothya's facilities in accordance with the company's policies, standards, procedures, and GMP. Key responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real-time review of manufacturing batch record documentation and logbooks, and collaborating with operations to resolve manufacturing issues.

Your Responsibilities

  • Perform QA shopfloor activities.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Conduct real-time reviews of manufacturing batch records.
  • Review manufacturing shop floor documentation.
  • Develop and maintain quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Your Profile

  • Bachelor's degree or higher in a relevant field (pharmaceutical, chemistry, biology, etc.).
  • Minimum 5 years of relevant work experience, with at least 3 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.
  • Knowledge of regulated cGMP warehousing, Quality, and compliance environments, with a preference for experience in GMP Manufacturing operations and processes.
  • Ability to recognize and resolve quality issues, inform management of proposed solutions, and seek guidance on complex issues.
  • Confident in making decisions for non-routine issues in agreement with management.
  • Develop and revise procedures.
  • Prepare written communications and convey problems to management with clarity and accuracy.
  • Knowledge of global cGMP requirements.
  • Adaptable and focused on quality matters.
  • Proficient in English; 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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