Pharma QA & CAPA Specialist

Artech LLC.; Morristown (NJ); On-site; USD 60,000 - 90,000; Full time

Job summary

A leading IT staffing company located in Morristown, NJ is looking for a Technical Recruiter specializing in Clinical/Scientific roles. The ideal candidate will have expertise in quality event management, CAPA systems, and knowledge of pharmacovigilance regulations. Familiarity with Microsoft software such as Project, Outlook, and Excel is also required. The role involves supporting QC of regulatory documents and managing CAPA activities related to both internal deviations and inspection commitments.

Qualifications

• Knowledge of Pharmacovigilance regulations and standards.
• Experience with audits and inspections of Pharmacovigilance systems.
• Strong skills in using Microsoft Project, Outlook, and Excel.

Responsibilities

• Manage significant quality events within WSR through CAPA plans.
• Support QC of regulatory inspection documents.
• Manage CAPAs in the Pharmacovigilance space.

Skills

Knowledge of Quality Systems

Knowledge of CAPA systems

Project management skills

Knowledge of Microsoft software

Job 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

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

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

Office: 973.967.3348 | Fax: [phone]

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