Title: Team Member - Plant IT
To perform the IT related activities as defined in individual Instrument/ Equipment SOP’s
Responsible as Administrative rights holder for Instrument / Equipment software available in Production, Warehouse and engineering area.
Monitor Backup generated by various software and review backup report
To review software validation documents like URS, SRS, FRA, IQ, OQ, PQ etc.
To perform the in-house computer system hardware qualification as predefined protocol.
To prepare and implement the system and software control policies as defined in individual Instrument/ Equipment SOP’s
To maintain and secure 21 cfr part 11 compliance of Instrument/ Equipment available in Manufacturing area.
To maintain and secure Instrument/ Equipment administrator login ID, password and synchronize date & time
Responsible to implement and monitor backup policies including data archival, retrieval and challenge test to archival/ retrieval system in timely manner
To prepare and maintain IT related SOP’s used in Manufacturing area.
To maintain software inventory, active user lists for GxP software’s in used in Manufacturing area
To ensure that all training related activities are carried out as per schedule and procedure
To participate internal and external audits to respond on IT related points for Manufacturing area.
To synchronize date and time of Instrument/ Equipment available in Manufacturing area
To backup and restore the data of Instrument/ Equipment available in Manufacturing area
Monitoring, Execution & timely reporting for all the ongoing activities Project at respective Sides
Responsible for local administration in all computer and Server at site
To prepare SOP, related to IT department
Responsible to implement and monitor backup policies including data archival , retrieval and challenges tests to archival /retrieval system in timely manner
To Perform IT related activates as defined in Individual Instrument/Equipment SOP
Handling of QMS system
Handling of Compliance activities.