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Qa cleaning validation specialist

Basel
GXP CONSULTING Switzerland
Inserat online seit: Veröffentlicht vor 12 Std.
Beschreibung

PpAre 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! /p pGXP 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: /p pbIn order to continue to successfully support our various clients, we are currently actively looking for QA Cleaning Validation Specialist: /b /p h3Key Responsibilities /h3 ul liLead, design, and execute bcleaning validation strategies /b for manufacturing equipment and processes in GMP-regulated environments /li liDevelop, review, and approve bcleaning validation protocols and reports /b, including risk assessments, sampling plans, and validation strategies /li liDefine and justify bacceptance criteria /b (MACO, HBEL, carryover limits) in accordance with EU GMP Annex 15 and FDA guidelines /li liPerform brisk assessments (FMEA) /b and support bchange control, deviations, and CAPA investigations /b related to cleaning processes /li liExecute cleaning validation studies and ensure alignment with approved protocols, procedures, and regulatory requirements /li liAnalyze validation data and provide btechnical recommendations /b to improve cleaning processes, manufacturing performance, and CIP systems /li liSupport and review bCIP/SIP validation and equipment qualification /b activities /li liLead and contribute to bdeviation investigations /b, including root cause analysis and impact assessments for contamination issues (product, detergent, microbial) /li liGenerate bfinal validation reports /b with clear conclusions based on scientific data and regulatory expectations /li liCollaborate closely with bQA, QC, Production, and Engineering teams /b to ensure robust contamination control strategies /li liEns...

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