About the job
The function New Manufacturer and Product Qualification lead is a new function at Fagron Services BV.
Responsibilities:
- Establish qualification classification of (new) Pharmaceutical Raw material suppliers/manufacturers
- Establish qualification status of product – manufacturer combinations.
- Tasks, in order to fulfill the responsibilities:
- Coordinate and define appropriate audit schedule and evaluate and conclude on outcomes.
- Define qualification criteria based on Pharmacopoeia and (inter)national legislation
- Evaluate qualification package from individual manufacturers
- Initiate and support quality improvement projects at manufacturers to increase the quality level.
- Direct for subject manufacturers an international audit team (Mainly China)
- Contact with main suppliers
- Setup and maintain Quality KPIs related to qualification
Set yourself apart
You possess the following qualifications, background and abilities:
Required education:
Pharmacist or equivalent academic level through experience
Required experience:
QA, Production or in Tech Ops in API manufacturing on middle management level for 5 years.
Additional experience in Quality assurance or Quality control in Pharmaceutical industry is a positive advantage. International communication with regulatory and quality counterparts and regulators. Auditing and risk analysis and - management
Knowledge:
- EU and USA FDA GMPs
- CFDA GMP is an advantage
- International legislation on API manufacturing
- Fluent in Dutch and English (verbally and speaking)
Competencies:
- Independent and responsible attitude
- Self-starting and self-motivating
- Decisiveness
- Ethical behavior and attitude
- Result oriented
- Quality mindset
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.