For a fast-growing, international, and dynamic pharmaceutical company that focuses on eliminating the burden of chronic cancer care, we are looking for someone to fill an exciting senior position involving quality assurance that enjoys working accurately, organized and in a dynamic, fast-paced environment.
Job description
As a Senior quality systems specialist you manage the deployment and management, including the training, of the company's quality systems in a broad sense. You interact, as a compliance partner, with many departments both internally and across site stakeholders. You are part of a small team in which people of all backgrounds and experiences are respected, which works together to save lives by working towards the cure for cancer. Jr. quality system specialists report to you and you make sure the team works to it's full potential. Does this sound interesting to you? Apply now!
Responsibilities
- Working on site level as a member of cross site quality system committees
- Managing the change control system and deliver training
- Managing the deviation and CAPA management systems
- Training staff and keep training schedules up to date
- Supporting regulatory inspections and audits
- Reviewing and approve proposed changes to systems and procedures
- Providing compliance guidance to product development projects and technical transfer activities
- Leading a small team of quality systems specialists
Profile
- At least a Bachelor's degree or higher in a technical discipline (Chemistry, Microbiology, Pharmaceutical Sciences, Engineering, or similar)
- At least 5 years of experience working under GMP regulations and with pharmaceutical law and legislation
- At least 5 years of experience with change control, CAPA, internal audits, deviations, and other ICHQ10 quality systems
- Proficient in Exception management systems and MS Office
- Experience with ASQ, Black/Green Belt, and/or ATMPs is preferred
- Strong written and verbal communication skills in English
- Communicatively strong and able to work independently.
Practical information and benefits
- Contract: start through Oxford, long-term position
- Salary indication: €5500 - €6000,- gross per month
- Full time position, 40 hours per week, 32h discussable
- After initial training, a hybrid form of working from home is possible
- Region: Amsterdam
Vacancy number: 21402
IMPORTANT NOTE: Please do not apply if you do not have a valid working permit in the Netherlands. Your application will not be processed.
