QA CSV Specialist

ph3QA Specialist – CSV Remediation /h3 pbJob Title: /b QA Specialist – CSV Remediation /p pbCompany: /b Inova ( /p pbLocation: /b Switzerland /p pbContract Type: /b Full-time, On‑site /p pbOpen Positions: /b 2 /p pbStart Date: /b ASAP /p h3About Inova /h3 pInova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high‑value expertise in quality, compliance, engineering, and digital transformation. We help our clients strengthen their operational capabilities and build robust, inspection‑ready quality systems across manufacturing environments. /p h3Position Overview /h3 pWe are seeking two experienced QA Specialists, CSV Remediation to support a pharmaceutical manufacturing site preparing for an upcoming Swissmedic inspection. /p pRecent assessments have identified compliance and validation gaps across several production and automation systems, including MES, SCADA, Factory Layer, and related shop‑floor applications. Your role will be to provide QA oversight and drive the remediation of these findings, ensuring that each system is supported by a clear, complete, and inspection‑ready documentation package. /p pThis assignment requires a strong QA and CSV background combined with a pragmatic approach. You will need to distinguish between issues that can be resolved immediately and those that depend on site‑level QA governance that is still under development. /p pThis is a QA oversight position. You will supervise, review, and approve testing activities performed by the relevant system teams rather than execute testing directly. /p h3Key Responsibilities /h3 ul liReview and remediate findings identified during internal assessments of manufacturing and automation systems /li liDefine pragmatic remediation priorities based on compliance risk, inspection readiness, and operational feasibility /li liResolve immediately actionable gaps in collaboration with system, automation, IT, and manufacturing teams /li liIdentify, justify, and formally document remediation items that depend on broader site QA governance or future procedural decisions /li liBuild a complete, inspection‑ready documentation package for each assigned production system /li liEnsure that each system package can be presented clearly and independently during the Swissmedic inspection /li liProvide QA oversight of testing activities performed by system and technical teams /li liReview and approve validation protocols, test evidence, reports, deviations, and supporting documentation /li liVerify that remediation activities comply with applicable GxP, CSV, data integrity, and quality requirements /li liSupport the preparation of system owners and technical teams for inspection‑related discussions /li liTrack remediation progress, elevate risks, and ensure delivery against inspection deadlines /li liCollaborate closely with QA, Manufacturing, Automation, IT, Engineering, and System Owners /li /ul h3Profile Requirements /h3 ul liDegree in Life Sciences, Engineering, Computer Science, Automation, or a related discipline /li liMinimum 5 years of experience in QA and/or CSV within a pharmaceutical, biotechnology, or regulated manufacturing environment /li liStrong experience with manufacturing and production systems such as MES, SCADA, Factory Layer, automation platforms, or comparable shop‑floor systems /li liSolid understanding of GxP requirements, computerized system validation, data integrity, and the system lifecycle /li liExperience reviewing and approving validation documentation and test evidence from a QA perspective /li liAbility to operate effectively in an environment where quality governance and procedures are still being developed /li liStrong QA mindset combined with a pragmatic, risk‑based approach /li liExperience supporting a new production line, greenfield facility, or site start‑up is highly desirable /li liAutonomous, structured, and delivery‑oriented working style /li liAbility to manage multiple systems and remediation workstreams simultaneously /li liStrong stakeholder management and communication skills /li liFluent English required /li liFrench is not required /li /ul h3Why Join Inova? /h3 ul liContribute directly to the inspection readiness of a pharmaceutical manufacturing site /li liTake ownership of high‑impact CSV remediation activities across critical production systems /li liWork at the intersection of QA, manufacturing, automation, and digital systems /li liApply your expertise in a pragmatic environment with clear delivery objectives /li liJoin a dynamic team that values autonomy, precision, collaboration, and accountability /li /ul pInova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace. /p /p #J-18808-Ljbffr