Particle Measuring Systems specializes in viable and nonviable particle counters that measure and monitor contamination levels in clean and controlled environments. Since 1972, our knowledgeable and experienced team has been developing innovative technologies to advance the cleanroom monitoring industry. Led by our technology which provides accurate and reliable results and information for our clients, Particle Measuring Systems is one of the world’s leading companies and manufacturers for particle counting instruments, and molecular and microbial monitoring. We are looking for a:
Pharma GMP Advisor – German Speaker
The candidate must have a comprehensive understanding of the organization’s advisory models and methodologies and provide a full range of advisory services and works within his/her personal area of expertise. The candidate will have the following tasks and responsibilities:
1) Project Execution
- To work with the Advisory team or individually based on the project needs;
- To prioritize his/her own workload and prioritize the workload of the project team in order to achieve the project scope and objectives;
- To capitalize on opportunities to improve project efficiency, results or team performance;
- To complete assigned project activities as well as facilitate business decisions;
- To produce quality work that meets the expectations of the client.
2) Thought Leadership
- To deliver presentations at seminars and industry group meetings;
- To author articles for publication in industry magazines, newsletters, book chapters and other forums;
- To provide pre and post-sale technical and application support;
- To analyze customer data for process improvements and understanding;
- To create application notes and technical papers.
3) Advisory Activities and Relationship Management and Business Development
- To apply the appropriate organization’s advisory models and methodologies and assist in the design/improvement the methodologies when needed;
- To provide a full range of technical and/or business advisory services within personal area of expertise including representing clients to regulatory agencies;
- To complete project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction;
- To facilitate resolutions to possible problems or conflicts within the project team and/or the client;
- To plan and deliver services and solutions which result in clients expressing satisfaction with service provided and occasionally result in additional business;
- To identify opportunities for follow-on business or changes in project scope and to exploit the opportunities with PC management and account management.
Education and Experience:
- Master’s degree in Biology/Chemistry/Biotechnology;
- At least five years’ experience with expert level industry or regulatory knowledge experience in Pharmaceutical sterile and not sterile and with a regulatory agency (such as FDA, EMA, AIFA).
- Must have a valid driver’s license, good driving record and the ability to obtain a passport;
- Availability to travel, including domestic, international and overnight and/or weekend stays;
- Deep knowledge of GMP practices;
- At least fluent oral and written English and German. Italian would be a plus.
The candidate we are looking for will be based in Germany or Switzerland or Austria and could be home-office based.
If you are interested in this opportunity, please send your updated CV to [email protected]
We do not make any distinctions based on race, gender, sexual orientation etc.