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XTN-3A11449 | CSV COMPLIANCE SPECIALIST

United States · remote · Salary not listed

Role overview

We are seeking a skilled and experienced CSV Compliance Specialist to join our team. The CSV Specialist will be working in the Digital Solutions team under the supervision of the Head of Enterprise Applications and the Henka Programme Manager.

He/she will work closely together with the GC Global SAP team members, Digital Solutions team, globally located Business Process Experts (BPEs), end users, externally hired contractors, the SAP partner and SAP.

Health Insurance/HMO
Enjoy unlimited MadMax Coffee
Diverse learning & growth opportunities
Accessible Cloud HR platform (Sprout)
Above standard leaves

Developing validation documentation for a leading oral health company, supplying world-class quality products and services to all dental professionals worldwide.
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.
Analyzes, reviews and approves change controls
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.
Keeping up to date with advances in the CSV field, regulatory requirements and good practice guidance.
Working with process owners to identify and implement new systems and upgrade existing systems to aid improvements to compliance and reduce risks to patient safety, product quality and data integrity.
Participating in both internal and external audit inspections from a CSV perspective.