Ph3Job Description /h3 pLocated in Switzerland at Kaiseraugst, the CSV Manager will join the Quality Assurance team, supporting quality operations for testing services in a Good Manufacturing Practices (GMP) laboratory environment. /p pThis position is responsible for ensuring compliance with regulatory requirements related to computerized systems, including validation, maintenance, and lifecycle management in accordance with internal standards and applicable GMP guidelines. /p pContract: 18 months, 50% employment level (part‑time). /p h3Responsibilities /h3 ul liPerform or support internal and external audits of electronic systems to verify that systems are validated and maintained in a validated state in accordance with Solvias standards and regulatory requirements. /li liProvide compliance oversight for the validation and maintenance of electronic systems in accordance with Solvias computer system validation (CSV) procedures and regulatory requirements. /li liReview and approve CSV deliverables such as Validation Plans, Requirements, Test Scripts, Trace Matrices, Validation Summary Report, etc., associated with the validation and maintenance of computerized systems. /li liReview procedures to ensure that the procedures contain the appropriate controls to ensure that computer systems are in a state of control. /li liProvide management with updates on projects, health of the CSV process and communicate risk‑based escalation issues, when applicable. /li liSupport resolution of CSV deviations/errors and provide compliance oversight to software validation projects. /li liAssist in the management and/or oversight of other external resources for CSV‑related activities. /li liWrite, contribute to or edit, as appropriate, SOPs related to the validation of GxP computer systems and/or the use or administration of the validated system(s). /li liAssist in the development of training materials related to the validation of GxP computer systems and/or the use or administration of validated systems. Works closely with IT and software/system vendor(s) as needed to ensure user/design materials and test documentation can be leveraged and is acceptable. /li liApply knowledge of cloud‑based, SaaS systems, thoroughly interpret CSV regulations, guidelines and GxP practices and meet regulatory compliance and corporate business requirements. /li liLiaise with IT and other cross‑functional business teams to ensure that Solvias electronic systems for issue management and general IT compliance support. /li liUp to 20% travel required. /li /ul h3Qualifications /h3 ul liBachelor's degree in technical, scientific or other relevant academic discipline and a minimum of 7 years of experience in a pharmaceutical, biotechnology or related environment combined with a minimum of 3 years of experience in oversight or management of GxP Computer System validation (or equivalent experience and/or education). /li liDemonstrated knowledge and understanding of applicable GxP or regulatory authority regulations and guidances activities and compliance (such as GCP, GPvP, GLP, GMP, GAMP, Part 11, Annex 11, ICH E6, OECD, etc.). /li liDemonstrated ability to lead and perform computer system QA audits and oversight of validation activities. /li liAbility to influence without direct authority. /li liExcellent verbal and written communication and skills. /li liAbility to work independently and collaboratively, as required, in a team environment consisting of internal and external team members. /li liAnalytical thinker with excellent problem‑solving skills and the ability to adapt to changing priorities and deadlines. /li liExcellent planning, organization and time management skills including the ability to support and prioritize multiple projects. /li liKnowledge of word‑processing, spreadsheet, and database applications. /li liKnowledge of pharmaceutical research and development processes and regulatory environments. /li liConsiderable knowledge of quality assurance processes and procedures and industry expectations. /li liStrong interpersonal skills. /li liExperience with computerized systems implementation, CSV program implementation, and acting as a subject‑matter expert for audits and inspections. /li /ul /p #J-18808-Ljbffr