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QA Officer Shopfloor Operations
Prothya BiosolutionsAmsterdam, Noord-Holland, NL30+ dagen geleden
Salaris
€ 2.000,00 per maand
FunctieomschrijvingBSc 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. You are action-oriented and skilled in decision-making, planning and organizing, coaching others, and analytical thinking. You have sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes. Knowledge of aseptic filling is an advantage. You routinely recognize and resolve Quality issues; informs management of proposed solutions. You seek management guidance on complex issues. You can recognize conflict and notify management with proposed recommendations for resolution is an advantage. You require moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. You are confident in making decisions for non-routine issues in agreement with management. You develop and revise procedures. You can prepare written communications and communicate problems to management with clarity and accuracy. You have knowledge of global cGMP requirements. You are a person who is adaptable without losing your focus on quality matters. English is a must; Dutch is an advantage. 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
The QA Shopfloor Operations Officer is responsible for quality activities at Prothya's facilities in Amsterdam, in accordance with Prothya's policies, standards, procedures and GMP. The functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues, among others.
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 shop floor 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.
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