Quality Assurance Specialist cGMP Manufacturing Operations
2 dagen geleden
The Quality Assurance Specialist in cGMP Manufacturing Operations at Prothya Biosolutions is responsible for ensuring quality activities are executed as per company policies, standards, and procedures. This role involves manufacturing compliance with applicable procedures and batch records, real-time review of manufacturing documentation, and collaborating with operations to resolve issues.
Your Responsibilities:- Ensure QA shopfloor activities are conducted according to established protocols.
- Maintain manufacturing compliance with relevant procedures and batch records.
- Perform real-time reviews of manufacturing batch records and logbooks.
- Review manufacturing shop floor documentation to guarantee accuracy.
- Utilize planning, organizing, and decision-making skills to optimize performance.
- Demonstrate knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Bachelor's degree or higher in a relevant field (pharmaceutical, chemistry, biology).
- A minimum of 5 years' experience in a Quality Assurance role or equivalent combination of education and experience acceptable.
- Action-oriented individual skilled in decision-making, planning, coaching others, and analytical thinking.
- Proven expertise in regulated cGMP warehousing, Quality, and compliance environments, preferably with GMP Manufacturing operations and processes knowledge.
- Aseptic filling expertise is advantageous.
- Capable of recognizing and resolving Quality issues; informing management of proposed solutions and seeking guidance on complex matters.
- Ability to recognize conflict and notify management with proposed recommendations for resolution.
- Requires moderate direction for complex tasks but can complete routine tasks with minimal supervision.
- Confident in making decisions for non-routine issues in agreement with management.
- Develops and revises procedures.
- Prepares written communications and conveys problems to management with clarity and accuracy.
- Familiarity with global cGMP requirements.
- Adaptable while maintaining focus on quality matters.
- English proficiency is mandatory; Dutch language skills are an advantage.
- Full-time employment.
- 8.33% annual bonus and 8.33% holiday allowance.
- Flexible working hours with consultation.
- Personal training budget of €2,000 every three years.
- Contribution to travel expenses from the first kilometer.
- Good accessibility via public transport and private parking.
- Pension plan through Zorg & Welzijn.
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