Validation Specialist Audit Trail
QLS are recruiting for a Validation Specialist to join an important project with a Global Pharmaceutical Company at their site based in Bern on a contract basis until end of September 2022 with option of an extension.
Main responsibilities:
- 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 systemsthat require it based on their categorization.
- Set up a maintenance task in SAP to plan subsequent reviews
Candidate’s Requirements:
- Degree in a Life Sciences/ Biotechnology, Chemistry discipline or comparable work experience
- Severalyears 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
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference QLS 00052148 in all correspondence.
