CSV Consultant

New Jersey, Raritan

Vacancy caducado!

Role: Computer System Validation Consultant

Location: Raritan, NJ (This is a hybrid position and candidates are expected to be on client site in Raritan, NJ 3 times a week. Vaccination is not required)

Duration: 12+ months

Note: Only W2, No C2CCSV SkillsetWe are looking for a Life Sciences Digital Quality and Compliance Senior Consultant, who has Experience in Life Sciences Industry, CSV, functional knowledge of Pharmaceuticals, Biologics, Medical Devices & Diagnostics and FDA regulations, knowledge of analytics and reporting tools, strong communication skills, proficiency in MS Office suite.Key responsibilities are as follows:
  • Experience designing, implementing and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management· Experience designing, implementing and navigating waterfall and agile SDLC (System Development Life Cycle)· Experience in SAP/ERP Validation and test management· Experience leading IT risk, IT quality and IT compliance transformational programs· Experience in executing Change Control, and Document management· Experience with IT Quality Management Systems and CAPA management systems· Experience designing IT risk, IT quality and IT compliance operating models· Experience designing and implementing IT quality and compliance life sciences controls for cloud products· General IT strategy experience· Knowledge of IT systems, applications and tools required
Qualifications – External
  • 4+ years working in the Life Sciences Industry· IT Risk, IT Quality and Compliance Management· Extensive knowledge of system development life cycle controls· Knowledge of lean and risk-based process and service attributes· Broad-based knowledge of industry leading practices for IT risk and compliance· Exposure to cross functional teams (lead, co-ordination),ability to deal with all employees and external business contacts while conveying a positive, service oriented attitude· Attention to detail, quality, time management and customer focus
Kind Regards

Prabhakar KumarRecruitment Manager

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lisWorkbr www.apolisrises.com

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