Risk _ RCTS_Q&C_ Non FSO, Staff

Job description

Key Responsibilities:

Provide guidance and share knowledge with team members and participate in performing procedures especially focusing on complex, judgmental and/or specialized issues. Work with the team and the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
Brief the engagement team on the client's IT environment and industry IT trends. Maintain relationships with client management to manage expectations of service, including work products, timing, and deliverables. Demonstrate a thorough understanding of complex information systems and apply it to client situations
Use extensive knowledge of the client's business/industry to identify technological developments and evaluate impacts on the client's business. Demonstrate excellent project management skills, inspire teamwork and responsibility with engagement team members, and use current technology/tools to enhance the effectiveness of deliverables and services. Understand EY and its service lines and actively assess what the firm can deliver to serve clients

Desired profile

Qualifications :

Knowledge and Skills Requirements:

Mandatory:

·  21 CFR Part 11 knowledge – Electronic Signatures and Electronic Records, Controls for Open Systems and Closed Systems
·  EU Annex 11 knowledge – Scope: computerised systems used as part of a GMP regulated activities
·  Computer System Validation Knowledge in Pharmaceutical/Medical Devices
·  GAMP 5 and it's good practice guides knowledge
·  Life Cycle Model and Phases as per GAMP – Concept, Project, Operation and Retirement
·  Project Phases as per GAMP – Planning, Specification, Build/Configure, Verification and Reporting
·  Good knowledge on Documentation – Preparation and review
·  Work experience in matrix organization or onsite – offshore model
·  Good Communication Skills
·  Minimum understanding on any one of predicate rules
·  Good Manufacturing Practice (ICH Q7, 21 CFR Part 210 and 211)
·  Good Laboratory Practice (21 CFR 58, OECD)
·  Good Clinical Practice (ICH E6)
·  Good Distribution Practice (21 CFR 210/211, and USP 1079)
·  Good Vigilance Practice (ICH E2A to ICH E2F)
·  Work experience with few Enterprise Systems like
·  ERP (SAP, Oracle etc…)
·  LIMS (LabWare, LabVantage etc…)
·  eQMS (TrackWise, Reliance ETQ, Master Control X etc…)
·  MES (Camstar, Rockwell etc…)
·  CDS (Empower, Chromeleon etc…) and SDMS (NuGenesis)

Good to have:

·  Consulting experience
·  Flexible for work timing