Qualification & Validation Consultant

vor 1 Monat

Reinach, Schweiz Arcondis Vollzeit
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.Tasks and responsibilities- Qualification of Equipment, instruments and facilities 
- Preparation of qualification and validation plans for laboratory and production-related processes 
- Preparation and review of specifications and risk analyses 
- Planning and witness SAT, FAT 
- Planning and execution of IQ-OQ-PQ 
- Processing of changes and deviations 
- Creation of Standard Operating Procedures (SOPs) 
- GMP-compliant documentation   
- Maintenance and archiving of documents 
- Ensuring training standards 
- Support of pharmaceutical release laboratories in GMP activities 
- Support in business developmentYour profile- Successfully completed scientific or technical studies (for example: Pharmacy, MedTech, Biotechnology, Engineering, Chemistry) or technical apprenticeship 
- Practical experience in a pharmaceutical laboratory, MedTech or production environment 
- Very good GMP knowledge and in-depth knowledge of other regulatory requirements 
- Practical experience in quality assurance 
- Professional experience in qualification of laboratory equipment and facilities is an advantage 
- Experience in method validation of analytical methods is an advantage 
- Experience in LIMS or MES environment is an advantage 
- Careful, self-contained, and responsible way of working 
- Very good German and good English language skills as well as strong experience in working with computer systems 
- High degree of quality awareness, strong communication skills and the ability to work in interdisciplinary teams 
- Willingness to travel

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