Mission.
Key responsibilities
Responsible for providing fit-for-purpose quality partnership and oversight on automated systems implementation for Vx Clinical Laboratories & Assay Portfolio (VxCL&AP) & HBSM Central Team (HBSM CT) in order to secure effective pipeline delivery, audits/inspections and regulatory submission approvals.
The aim of the mission
1. Ensure that business processes, equipment and computerized/automated/analytical systems are developed, qualified or validated in compliance with applicable internal requirements (processes) and external standards such as (GCLP, GCP and IS0 9001:2015)
2. Provide QA expertise and support to related stakeholders and teams
3. Work with interdisciplinary teams to ensure quality standards are met throughout the automation lifecycle and ensure “one voice quality”
4. Review and approve from a quality perspective, if appropriate, relevant documentation linked to GCLP/GCP and CSV activities
5. 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 GSK procedures
Required profile.
At least 0-3 years of experience in Quality and CSV in Pharmaceutical or Biotech company.