4-6 years with 2/3 E2E Implementations, Pharma experience would be added advantage
Championing full lifecycle validation for all applicable computerised systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
Validating manufacturing, laboratory and other business systems.
Working with project teams to compile user requirements for local and group software systems.
Carrying out risk assessments and periodic reviews throughout system lifecycles to ensure systems are maintained in a validated state during their operational life.
Using quality risk management to deliver scalable approaches to CSV.
Authorizing validation plan deliverables and CSV COPs / policies.
Writing test plans / scripts and carrying out documented black box testing throughout systems lifecycles.
Participating in Performance Qualification (PQ) and User Acceptance Testing (UAT) ensuring that the appropriate documentation of testing is performed.
Working with system vendors to leverage appropriate information and documentation into Sterling CSV activities.
Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
Benefits
Working with system vendors to leverage appropriate information and documentation into Sterling CSV activities.
Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
