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Sr. Specialist Global Quality Systems

Newark Metro Area, NJ

Posted: 06/05/2018 Job Type: Scientific Job Number: JN -062018-21767
1. Primary responsibility will be to support GMP Systems enhancements and inspection readiness with eQRMS
a. Manages changes to eQRMS GMP systems (Deviation, CAPA, Complaints, Change controls).
b. Facilitates changes to user requirement Documents
c. Supports generation of UAT/execution of UAT scripts
d. Updates/Creates Training materials.
e. Supports Training objectives with User community
f. Ensures open CAPA and audit commitments are closed within due dates
2. Facilitates Data integrity assessments for GMP Systems.
a. Conducts eQRMS module assessments per procedure
b. establishes Data integrity assessment best practices
3. Additional responsibilities may include:
a. Project support for eQRMS and QUADs business owners.
b. Support Integration activities
c. Backup Systems SME support
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