Computerized Systems Validation Expert
CDI - Executive Status
ADN is a consulting and services company specializing in the regulatory compliance of computerized systems in the pharmaceutical and medical device sectors.
With 40 employees, ADN is a leader in the field of operating for large healthcare accounts. With more than 20 years of expertise, ADN shines in France in the Paris and Lyon regions as well as abroad and in particular in Singapore.
The objective is to accompany and support ADN customers in their digital transformation and on IT compliance issues without compromising regulatory compliance, at the lowest cost.
As part of our development, you will develop expertise within the R&D department on the validation of computerized laboratory systems (HPLC, LIMS, Equipment, etc.).
The consultant can progress to management or commercial functions.
You will be assigned the following responsibilities:
• Operational or support missions on customer projects
• Validation plan
• URS (Collection of requirements and regulatory advice), risk analyzes
• Test Protocols and Scripts
• Traceability matrices
• Validation report, associated procedures
• Methodology of GAMP 5
• 21 CFR part 11, 210, 211, 58, BPL
Required profile :
You are proactive, have good interpersonal skills and know the best practices of the pharmaceutical industry, in compliance with GxP and FDA standards. The control of the regulations is the subject of a voluntary and autonomous process depending on the customer context, in particular on the FDA guides.
Fluency in the English language is a key skill, like that of project management. Experience with computerized systems on the market (Empower or Labware) would be a plus.
The training on the pillars is provided by ADN (Part 11, Part 210 & 211, Annex 11, ISPE GAMP Guides), as well as the Data Integrity training (technical and procedural).
You are motivated, determined and want to seize an opportunity for professional development and diversity in missions.
Contact: email@example.com; Gratuity: according to experience.