We are looking for technical specialists with experience in pharmaceutical industry. You are responsible for (c)GMP compliance, deviations and change control in the COVID-19 vaccine test team. You will contribute to reliable analytical data for stability studies and in process control. If you are a subject matter expert in the field of sample management, apply now.
Job description
In the manufacturing site of the COVID-19 vaccine the test team is responsible for the execution of all analytical testing methods. In this position you are the expert in sample management. As technical specialist you are responsible for handling quality and compliance issues, CAPA's, deviations and change control. You act as SME during cGMP audits and inspections and will be the point of contact in technology transfer projects.
Responsibilities
- Deviation management; lead investigator for non-conformances and applying the correct preventive and corrective actions.
- Responsible for quality issues, lab investigation and CRA's.
- Time management of closing investigations in a timely manner.
- Leading continuous improvement processes.
- Participating in and leading both short- and long-term projects.
- Expert in separation techniques, represent the team during meetings.
- Ensuring cGMP compliance, supporting technical implementation of assays in an efficient and safe manner.
- GAP analysis, writing reports and protocols.
Profile
- BSc or MSc in bioscience, pharmacy or biochemistry. (PhD is overqualified).
- 1-6 years of relevant working experience in (bio)pharmaceutical industry.
- Knowledge of sample management processes in pharmaceutical industry.
- Proven excellent knowledge on GMP-guidelines.
- Good technical writing skills in English.
- Knowledge of statistical data analysis.
- Excellent communication and decision-making skills.
- You have a valid working permit for the Netherlands.
Terms of employment
- One-year temporary project, contract trough Oxford Global Resources.
- Salary indication: from €3000 to €5000 gross per month
- Working hours: fulltime; 40 hours per week.
- Location: Leiden region
Vacancy number: 15815
