Computer System Validation Quality Partner
Brabant Wallon – contracting
What are your responsibilities?
- Ensure that business processes, equipment and computerized/automated/analytical systems are developed, qualified or validated in compliance with applicable internal requirements 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 internal procedures
- Review and approve deviations/CAPA, procedures and all documentation supporting business processes.
Who are you ?
- At least 1-3 years of experience in Quality and CSV in Pharmaceutical or Biotech company
- Experience in computerized 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, especially 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.
Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
