Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Skills
Auditing
GMP
Quality Assurance
Continuous Improvement
Quality Control
Job Details
Hello Professionals,
This is Karthick from Vega Intellisoft
Role : QC Investigations Expert
Location : Morris Plains, NJ (On site)
Duration : Long term contracta
Experience : 2- 5 Years
Job Description :
- Support in continuous improvement by participating in deviation investigations, CAPA management, and change control.
- Perform quality assurance oversight for manufacturing operations and support GMP compliance
- Lead and participate in Quality Management Reviews (QMR) to analyze key quality metrics such as deviations, CAPAs, audit findings, and complaints.
- Collaborate cross-functionally with Quality, Manufacturing, Validation, and Regulatory teams.
- Experience supporting cGMP manufacturing operations especially for therapies like cell therapy through administration and enforcement of the Quality Management System.
- Working knowledge of cGMP/ICH/FDA/EU regulations and experience in US and international regulations.
- Direct experience reviewing and/or authoring Standard Operating Procedures (SOPs).
- Excellent oral and written communication skills with technical writing experience required.
- Contribute for conduct of thorough investigations like OOS/OOE, OOT & RCA studies.
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