New position for a Quality Assurance Specialist within a large international pharmaceutical concern in Leiden!
Job Description
For one of our clients within the pharmaceutical industry we are looking for a Quality Assurance Specialist with expertise in batch record review, deviations, CAPA plans and a proven track record in an FDA or similar regulated environment. In this role you are responsible for the communication with external sites, traveling is common for up to 25% of your time. Strong interpersonal and written/oral communication skills are essential within this role as well as the ability to build connections with stakeholders and manage across cultures.
Responsibilities
- Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets.
- Evaluate batch manufacturing records, deviations, and associated CAPA plans and identify issues which may impact the quality of the product or the compliance to marketing authorizations.
- Independently resolve minor issues
- Consult with the account manager as needed for resolution of major issues
- Ensure that all relevant QA related concerns at external manufacturing sites are raised to expected management.
- Ensure manufacturing operations external manufacturing sites are executed in a compliant manner
- Proactively identify risks and potential issues and delays in market release, and where possible, drive resolution.
- Extensive (> 3 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production)
- Able to connect easily, team worker, able to manage across cultures
Requirements
- BSc or MSc with relevant QA experience;
- A minimum of 8 years working in an FDA or similar regulated environment; Quality Assurance experience preferred
- A minimum of 5 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production)
- Able to build connections with stakeholders, and manage across cultures
- Strong interpersonal and written/oral communication skills
- Proficient in applying process excellence tools and methodologies
- Amount of travel 25%
- English mandatory, other languages are a benefit
- Valid Dutch work permit is a must, candidates not in possession of a work permit will not receive a response;
Benefits
- Contract: 1 year via Oxford, realistic long- term perspective;
- Salary: €4631- €5700 gross monthly based on a full-time position;
- Holidays: 25;
- Working hours: full-time, 32 hours possible; remote work is possible for this position
- Region: Leiden;
- Vacancy number: 21755;
