Research & Development
Secondment via YER
Food, Feed, Pharma
Over deze vacature
For our client in the region of Oss we are looking for an Environmental Monitoring Specialist.
The Environmental Monitoring Specialist provides direct Technical Services to a production area. The Specialist with guidance from the Technical Services Leadership team, ensures product/process quality and performs activities to facilitate the release of product to the marketplace. The Specialist is responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas, and leads all investigations into environmental excursions. This position also works closely with the assigned end-to-end in a team environment to ensure timely completion of responsibilities, creation of effective corrective/preventative actions, with emphasis on right first time. Will become knowledgeable in Federal and other regulatory agency requirements and GMP's to assure that all areas operate in a state of compliance. Works with moderate work direction and is skilled and knowledgeable to the position.
- Coordinate and resolve Quality Notifications (events) related to EM and UM excursions;
- Define and implement corrective and preventive actions;
- Trending of EM and UM data including reporting;
- Able to collect data, interpret and translate to periodic reports;
- Closely interact with and support manufacturing and quality personnel in all aspects of EM observations, process improvements and investigations;
- Maintain current knowledge of regulatory and industry standards, trends and advancements in EM and UM.
A large and versatile company for pharmaceuticals in the Netherlands. They offer innovative treatments for a better human and animal health.
- In return for your hard work you will be rewarded with an excellent salary and fringe benefits
- Fixed salary commensurate with knowledge and experience
- An attractive package of employee benefits
- The terms of employment offered are exceptionally good
- A competitive package of employee benefits
Experience with Environmental Monitoring.
Previous experience in an aseptic manufacturing environment. Attention to detail.
- Minimum B.Sc. in Microbiology, Biotechnology, Biochemistry, Engineering or equivalent;
- Minimum of 2 years of experience in aseptic or sterile processing in clean-rooms with high focus on microbiology (highly preferable);
- Experience in Root Cause Analysis
- Experience to work with common programs like MS Excel and Word
- Thorough understanding of cGMP, Regulatory expectations, and international industry guidelines;
- Ability to work independently with minimum supervision;
- Must be proactive, results oriented, and have a strong attention for detail;
- Analytical and organisational mindset;
- Project Management skills (preferably);
- Strong people and communication skills to communicate with all layers of the organisation;
- Excellent verbal and written communication skills in both Dutch and English language.