Quality Assurance
artechConvent Station (NJ)
Quality Assurance
Posted 54 days ago
artechConvent Station (NJ)
SENIORITY
Manager
About the role
Company Description:
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
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 Qualifications
Skills:
Knowledge of PV, project management skills a plus, knowledge of microsoft software, ie. project, outlook, excel.
Additional Information:
- Sneha Shrivastava
- Technical Recruiter (Clinical/Scientific)
- Artech Information Systems LLC360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3348 | Fax: 973.998.2599 Connect with us on - LinkedIn | Facebook | Twitter
Summary
Type: Contract
Function: Quality Assurance
Experience level: Mid-Senior Level
Industry: Pharmaceuticals
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