Spezialist für QA Coompliance

ppFor our client, a global leader in biopharmaceutical manufacturing, we are seeking an experienced /ppbQA Validation Specialist (m/w/d) /b /ph3General Information /h3ullibStart Date: /b /lilibDuration: /b until /li /ulh3Tasks Responsibilities /h3ulliPerform QA oversight of qualification and validation activities to ensure GMP equipment, facilities, and systems remain in a validated and compliant state. /liliAssess and review change controls, deviations, CAPAs, and validation-related activities to ensure compliance with regulatory requirements. /liliProvide QA review and approval of SOPs, validation protocols, validation reports, and associated quality documentation. /liliSupport qualification and validation activities related to GMP equipment, facilities, clean utilities, autoclaves, controlled storage areas, shipping validation, and temperature mapping. /liliDevelop validation protocols based on validation plans and provide technical expertise throughout the validation lifecycle. /liliUtilize and maintain quality systems including DMS, LIMS, Kneat, and TrackWise for validation and quality management activities. /liliParticipate in audits, inspections, and continuous improvement initiatives to ensure compliance with EU GMP and FDA regulatory requirements. /li /ulh3Your Profile /h3ulliDegree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or a related scientific/technical discipline is preferred; equivalent experience will also be considered. /liliExperience within a GMP-regulated pharmaceutical, biotechnology, or Cell Gene Therapy environment. /lili2-6 years of experience in Validation and Qualification (CQV). /liliStrong understanding of IQ, OQ, PQ, validation lifecycle principles, and maintaining systems in a validated state. /liliExperience reviewing and approving SOPs, validation protocols, validation reports, deviations, CAPAs, and change controls. /liliPractical experience with change control processes and validation documentation review. /liliFamiliarity with EU GMP and FDA regulations. /liliFluent in English; German is a strong advantage. /li /ul /p #J-18808-Ljbffr