Qualification Assurance Specialist
In this critical role, you will be responsible for ensuring the quality and compliance of medicinal products in accordance with regulatory requirements. As a Qualification Assurance Specialist, you will provide guidance on quality matters, oversee the quality management system, and ensure that all necessary documentation has been completed.
About the Role
The successful candidate will be responsible for certifying medicinal products in accordance with EU Directives, Annex 16, and Annex 13 where applicable. They will also provide quality direction and guidance for projects related to processes, product, and compliance. Additionally, they will ensure independence on decisions on quality-related matters and provide support with investigations and resolution of discrepancies.
Responsibilities
- Ensure quality and compliance of medicinal products
- Provide quality guidance on critical and major quality matters
- Oversee quality management system, procedures, release, and compliance documents
- Ensure independence on decisions on quality-related matters
- Support investigations and resolution of discrepancies
Requirements
- Third level qualification in a science-related discipline
- Eligible and demonstrated ability to act as a Qualified Person within EC/EEA
- Minimum 3 to 5 years QP experience
- Excellent communication skills, including written, interpersonal, collaboration, and negotiation skills
- Extensive demonstrated pharmaceutical quality experience
- Thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing, and distribution processes, and associated global regulatory GMP/GDP requirements
Benefits
- Comprehensive Health Insurance coverage
- Paid Time Off
- ESOP/401K – 15% Company Contribution
- Company Paid Life Assurance
- Company Paid Income Protection/Long-Term Disability
- Career/Professional Development Opportunities