QA Validation Specialist

pJoin a transformative GMP expansion project and make a lasting impact through validation, compliance, and quality excellence. /ppProclinical is seeking a QA Validation Specialist to support a major expansion project in Switzerland. This role focuses on ensuring that GMP equipment, facilities, and systems are qualified, validated, and maintained in compliance with regulatory standards. You will work closely with operations, engineering teams, and regulatory bodies to uphold product quality and patient safety. This is an exciting opportunity to contribute to a critical phase of a large-scale manufacturing project in a collaborative and fast-paced environment. /ppPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /ppbResponsibilities: /b /pliOversee validation and qualification activities to ensure GMP equipment, facilities, and systems remain in a validated state. /liliSchedule and manage tasks for yourself and Level 1 team members as directed by the Validation Manager. /liliConduct change control assessments for GMP equipment, facilities, and systems to ensure regulatory compliance. /liliDevelop validation protocols based on validation plans, if applicable. /liliReview and approve SOPs, validation protocols, reports, change controls, deviations, and CAPAs. /liliPerform quality system activities, including managing documentation, validation systems, and tracking tools such as DMS, LIMS, Kneat, and Trackwise. /liliParticipate in audits and inspections to demonstrate compliance with EU GMP and FDA regulations. /liliProvide technical expertise in areas such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), autoclaves, clean utilities, shipping validation, temperature mapping, and controlled storage rooms. /liliSupport continuous improvement initiatives and other assigned duties. /lipbKey Skills and Requirements: /b /pliExperience in GMP-regulated pharmaceutical, biotech, or cell and gene therapy environments. /liliStrong understanding of validation lifecycle, including IQ, OQ, PQ, and maintaining systems in a validated state. /liliProficiency in change control processes and documentation review. /liliFamiliarity with EU GMP and FDA regulations. /liliExperience reviewing and approving SOPs, validation protocols, reports, deviations, CAPAs, and change controls. /liliProficiency in English; German language skills are a strong plus. /liliA background in science, engineering, biotechnology, chemistry, biology, pharmacy, or a related field is preferred but not essential if relevant experience is demonstrated. /liliAbility to work autonomously, adapt quickly, and thrive in a fast-paced, multicultural, and collaborative environment. br/ /li