Job Description
:
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 (GSK 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 GSK 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.