QA Validation Specialist

ppJoin a transformative GMP expansion project and make a lasting impact through validation, compliance, and quality excellence. /p pProclinical 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. /p pPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /p h3Responsibilities: /h3 ul liOversee validation and qualification activities to ensure GMP equipment, facilities, and systems remain in a validated state. /li liSchedule and manage tasks for yourself and Level 1 team members as directed by the Validation Manager. /li liConduct change control assessments for GMP equipment, facilities, and systems to ensure regulatory compliance. /li liDevelop validation protocols based on validation plans, if applicable. /li liReview and approve SOPs, validation protocols, reports, change controls, deviations, and CAPAs. /li liPerform quality system activities, including managing documentation, validation systems, and tracking tools such as DMS, LIMS, Kneat, and Trackwise. /li liParticipate in audits and inspections to demonstrate compliance with EU GMP and FDA regulations. /li liProvide 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. /li liSupport continuous improvement initiatives and other assigned duties. /li /ul h3Key Skills and Requirements: /h3 ul liExperience in GMP-regulated pharmaceutical, biotech, or cell and gene therapy environments. /li liStrong understanding of validation lifecycle, including IQ, OQ, PQ, and maintaining systems in a validated state. /li liProficiency in change control processes and documentation review. /li liFamiliarity with EU GMP and FDA regulations. /li liExperience reviewing and approving SOPs, validation protocols, reports, deviations, CAPAs, and change controls. /li liProficiency in English; German language skills are a strong plus. /li liA background in science, engineering, biotechnology, chemistry, biology, pharmacy, or a related field is preferred but not essential if relevant experience is demonstrated. /li liAbility to work autonomously, adapt quickly, and thrive in a fast-paced, multicultural, and collaborative environment. /li /ul pBy submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /p /p #J-18808-Ljbffr