Job Description :
Sound understanding of 21CFR part 11 guidelines and GMP processes
Hands on experience in creating/reviewing compliance lifecycle deliverable
Hands on experience in IT processes in manufacturing in validating Manufacturing system including MES, PLC systems
Good understanding of compliance documents across SDLC
Serve one of our leading pharma clients in support implementation of PLC and MES in a validated environment
Have to plan and execute validation actitivties independently, drive the team to perform test management activities in an automated environment, conduct risk assessment.
To provide guidance in configuring Manufacturing software, Backup / recovery / archives.
Creating compliance documents across SDLC
CSV validation for different industrial automation systems
Wriing SOP''s, testing, validation procedure documents
Defining workflows and user roles and responsibilities for various ind automation systems
Defining the procedures for Phrama compliannt process for validatiing different equipments
conducting and driving Regulatory Risk Analysis with business users and IT stakeholders
leading smaller teams in achieving compliance objectives
Ability to estimate time needed for compliance deliverable