Are you passioned about the Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a swiss consulting company with a passioned team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle in the following areas:
In order to continue to successfully support our various clients, we are currently actively looking for QA Cleaning Validation Specialist:
Key Responsibilities
* Lead, design, and execute cleaning validation strategies for manufacturing equipment and processes in GMP-regulated environments
* Develop, review, and approve cleaning validation protocols and reports, including risk assessments, sampling plans, and validation strategies
* Define and justify acceptance criteria (MACO, HBEL, carryover limits) in accordance with EU GMP Annex 15 and FDA guidelines
* Perform risk assessments (FMEA) and support change control, deviations, and CAPA investigations related to cleaning processes
* Execute cleaning validation studies and ensure alignment with approved protocols, procedures, and regulatory requirements
* Analyze validation data and provide technical recommendations to improve cleaning processes, manufacturing performance, and CIP systems
* Support and review CIP/SIP validation and equipment qualification activities
* Lead and contribute to deviation investigations, including root cause analysis and impact assessments for contamination issues (product, detergent, microbial)
* Generate final validation reports with clear conclusions based on scientific data and regulatory expectations
* Collaborate closely with QA, QC, Production, and Engineering teams to ensure robust contamination control strategies
* Ensure compliance with EU GMP, FDA regulations, and internal quality standards
Profile & Qualifications
* Master’s degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, or related field
* 5+ years of experience in Cleaning Validation / QA Validation within pharmaceutical or biotech industries
* Strong knowledge of GMP regulations (EU and FDA) and validation lifecycle principles
* Hands‑on experience with CIP/SIP systems and/or equipment qualification is an advantage
* Proven ability to write and review technical GMP documentation (protocols, reports, deviations, CAPAs)
* Strong analytical mindset with a structured and detail‑oriented approach
* Excellent communication and cross‑functional collaboration skills
* Languages: Fluent German
About us:
* Human‑sized company with colleagues from diverse cultural and professional backgrounds
* Joint team spirit
* Continuous learning and development thanks to internal trainings and workshops
At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you! Send us your application via email:
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