Specialist Quality Assurance
Location: NetherlandsThe Company
The mission of this company is to help patients. Every day they fully commit to better the life of sick people. With a focus on results of the treatment they do scientific research, development and creating the most effective medication.Role Description
As a Specialist Quality Assurance you will work within the Quality Regional Work cell in Europe reporting to the Senior Manager QA. Understanding and grasping a wide range of quality related competencies while providing high complexity tactical support to the Site leads across multiple Quality Systems and Processes. In addition to the Quality Assurance duties you may be assigned specific oversight and responsibilities for key processes improvements within the department.Responsibilities
- Manage and own NC, CAPA, Change Control records for External Quality- manage and drive Quality records to closure independently
- Perform Batch disposition activities in support of lot release
- Perform Continuous Improvements
- Demonstrate ownership for required training on Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints e.g.)
Requirements
- Bachelor's degree in a Scientific Field- Minimal 4 years' of experience in Quality and Manufacturing
- Extensive GMP Experience
- Ability to oversee multiple project, manage workload and timelines
- Understanding of the applicable Manufacturing/Testing Processes (Drug Substance, Drug Product, Packaging, Device Manufacturing processes)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
Opis stanowiska
The Company
The mission of this company is to help patients. Every day they fully commit to better the life of sick people. With a focus on results of the treatment they do scientific research, development and creating the most effective medication.Role Description
As a Specialist Quality Assurance you will work within the Quality Regional Work cell in Europe reporting to the Senior Manager QA. Understanding and grasping a wide range of quality related competencies while providing high complexity tactical support to the Site leads across multiple Quality Systems and Processes. In addition to the Quality Assurance duties you may be assigned specific oversight and responsibilities for key processes improvements within the department.Responsibilities
- Manage and own NC, CAPA, Change Control records for External Quality- manage and drive Quality records to closure independently
- Perform Batch disposition activities in support of lot release
- Perform Continuous Improvements
- Demonstrate ownership for required training on Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints e.g.)
Requirements
- Bachelor's degree in a Scientific Field- Minimal 4 years' of experience in Quality and Manufacturing
- Extensive GMP Experience
- Ability to oversee multiple project, manage workload and timelines
- Understanding of the applicable Manufacturing/Testing Processes (Drug Substance, Drug Product, Packaging, Device Manufacturing processes)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
Dodatkowe informacje
- Ostatnia aktualizacja
- Wymiar etatu
- Pełny etat
- Rodzaj umowy
- Własna działalność
- Liczba wakatów
- 1
- Min. doświadczenie
- 2 lata
- Min. wykształcenie
- Wyższe licencjackie
- Branża / kategoria
- Praca Kontrola jakości / Audyt produkcji