Junior Computer System Validation
Il y a 5 mois
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.
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