Quality Assurance

• Management of significant quality events within WSR through investigation and CAPA plan Transition of Hospira CAPA plans to Pharmaceutical systems Management of Hospira inspection Commitments including the transition to Pharmaceutical systems
• Support QC of regulatory inspection documents such as the PSMF , DDPS Support inspections and audits.
• Skills: Knowledge of Quality Systems , management of Corrective and Preventative Action plans Knowledge of Trackwise CAPA systems, QTS, GEMs etc
• Knowledge of Pharmacovigilance regulations and standards Some experience with audits and inspections of Pharmacovigilance systems Microsoft Document skills PV Quality management:
• Management of CAPAs in the Pharmacovigilance space, for both internally identified deviations and commitments resulting from Inspections

Skills: Knowledge of PV, project management skills a plus , knowledge of microsoft software, ie. project, outlook, excel.

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3348 | Fax: 973.998.2599

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