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Junior Computer System Validation
il y a 2 semaines
The CSV will be esponsible for providing fit-for-purpose quality partnership and oversight on automated systems implementation for Vx Clinical Laboratories & Assay Portfolio (Vx CL&AP) & HBSM Central Team (HBSM CT) in order to secure effective pipeline delivery, audits/inspections and regulatory submission approvals. **Responsibilities**: The aim of the mission is to: - Ensure that business processes, equipment and computerized/automated/analytical systems are developed, qualified or validated in compliance with applicable internal requirements (company processes) and external standards such as (GCLP, GCP and IS0 9001:2015) - Provide QA expertise and support to related stakeholders and teams - Work with interdisciplinary teams to ensure quality standards are met throughout the automation lifecycle and ensure "one voice quality" - Review and approve from a quality perspective, if appropriate, relevant documentation linked to GCLP/GCP and CSV activities - Support management of technical complex problems, evaluate potential impacts on quality and ensure that the critical topics are adequately and timely escalated to management in accordance with the company procedures - Review and approve deviations/CAPA, procedures and all documentation supporting business processes. **Requirements**: - At least 0-3 years of experience in Quality and CSV in Pharmaceutical or Biotech company. - Experience in computerised systems validation and equipment qualification. - Knowledge of compliance rules and recommendations for CSV area (21 CFR part 11, GAMP) and for Business in pharmaceutical industries (GCLP, GCP, GMP). - Knowledge of risk management principles and tools. - Strong knowledge and expertise of quality systems, specially Deviation, Change Control, CAPA. - Good communication and presentation skills. - Ability to manage stakeholders and build relationships transversally in a matrix environment. - Good knowledge of English (read, spoken and written). - Ability to manage time and priorities. - Analytical mindset. - Comfortable with the use of IT and computerized system tools. **Benefits**: - Full-time position. - Hybrid office/homework policy : 2 days on-site and 3 days remote - A balanced salary package based on your capabilities and experience, including extra legal benefits.
