For our client a Global Pharmaceutical Company in Bern, we are currently looking for a new team member as
Validation Specialist (QC equipment)
- Support closing a CPA regarding audit trail review for QC equipment
- Categorize all QC GxP systems according to global SOP and define the frequency of System Audit Trail review based on risk.
- Perform a System Audit Trail review for those systems that require it based on their categorization.
- Set up a maintenance task in SAP to plan subsequent reviews
Who we are looking for
- Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
- Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
- Good understanding of analytical technologies,
- Strong analytical thinking and problem-solving ability
- Excellent communication and teamwork skills
- Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
- Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
- Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
- Good verbal and written skills in English, German is a plus
Working Time: flexible working hours
Start Date: 01.12.2021
Duration: 09 months
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).