GMP Specialist
GMP Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
For our location in Nijmegen we are looking for an enthusiastic GMP Specialist to join the team. As GMP Specialist you will be responsible for leading/owning specific GMP related topics such as deviations change controls and documentation. You are responsible for ensuring these areas are fit for purpose and are in compliance with cGMP regulations. You will support the team with the maintenance and improvement of general GMP processes as well as collaborating closely with the operations department the equipment owners and the process engineers and other staff members. Responsibilities will include but are not limited to:
Documentation and Change Control:
- Being initiator and owner of project related change controls. This includes planning and organizing work-cell meetings and guiding the change controls through the relevant systems. This guidance also means protecting deadlines collection and combining of input and coordinating feedback and approval cycles.
- Contribute to project planning through maintaining the scheduling map and distributing meeting invitations as well as supporting the documentation of the project.
- Ensuring timely availability controlling the status of document routing and helping to identify bottlenecks and risks in the documentation process.
- Developing / implementing tools needed to ensure that change controls are executed in a compliant cGMP manner.
Deviations:
- Leading deviation investigations including product impact analysis and root cause investigations
- Ensuring that relevant corrections CPAs and/or improvements on production processes and systems are made within the department.
- Developing adequate measures to show effectiveness of the corrections and CPAs.
- Developing / implementing tools needed to ensure that deviations are executed in a compliant cGMP manner.
- Driving the timely and compliant completion of the deviations to ensure timely and compliant batch release.
General:
- Monitoring progress and Key Performance Indicators (KPIs) for your area of GMP expertise.
- Working precisely detecting and solving acute problems and escalating abnormalities.
- Communicating metrics and quality /compliance related topics to the right level of management or Quality Systems.
- Identifying and implementing continuous improvement activities.
- Supporting a safe healthy and sustainable work environment.
Qualifications :
- Bachelors (minimum) or masters degree in biotechnology biochemistry biomedicine process technology (or equivalent).
- Minimum of 3-5 years relevant work experience in a biotechnology or biopharmaceutical industry environment.
- Experience in a quality or GMP role in a cGMP environment is a must.
- Experience with computerized (quality) systems e.g. Trackwise TruVault
- Strong communication skills in English.
- Problem solving organizational and delegation skills.
- Ability to strive in a dynamic environment.
- Ability to work independently and within a cross-functional team.
- Accurate and attention to detail.
Additional Information :
Working at PSS means working with highly motivated people with a can-do mentality. Our people work in an international environment within an enthusiastic team and for an organization where there is sufficient room to develop further. Working together is extremely important to us and having fun in what you do is part of that! Our monthly team lunches team activities and the hand out of awards to our colleagues are an example of this. We also offer:
- A responsible and challenging position within the team;
- Plenty of room for your own ideas and input;
- Specialist training and a range of opportunities for personal and professional development;
- Flexible working hours;
- Good salary and benefits.
Working at PSS offers you the flexibility and personal touch of working in a medium sized and dynamic company whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for the motivated employees:
- Plenty of opportunities for growth;
- Varied work where you are in regular contact with other companies and scientists within the Eurofins group;
- A broad customer portfolio ensuring a lot of diversity in your work.
Would you like to know more
For questions regarding the position please follow the link below Im interested in order to contact the hiring manager.
Acquisition for this vacancy is not appreciated.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
