Job Description :
Compliance and Validation Consultant
Morgantown WV

Job Description:

- Primary skillset : Validation experience, quality documentation to be produced.
- 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
- Experience in driving the project teams in creating the compliance deliverables
- Experience in using HP ALM
- Experience in conducting and driving Regulatory Risk Analysis with business users and IT stakeholders
- Experience in leading smaller teams in achieving compliance objectives
- Ability to estimate time needed for compliance deliverable