Very Urgent Requirement
Job Title: QA Compliance Specialist
Location: Onsite –Indianapolis, IN (Onsite)
Contract Duration: 6+ Months (Extention)
Must have: GMP-regulated biopharmaceutical environment, QMR, APQR, FDA/ICH/EU cGMP
Description:
GMP Experience
- Minimum 8+ years in a GMP-regulated biopharmaceutical environment
Quality Assurance Experience
- At least 2+ years specifically in a QA role
QA Compliance Knowledge
- Strong knowledge of QA Compliance systems including:
- Quality Management Review (QMR)
- Annual Product Quality Review (APQR)
- Self-inspections
- Audit readiness
Regulatory Knowledge
- In-depth understanding of FDA/ICH/EU cGMP regulations and guidelines
Data Integrity
- Experience with Data Integrity principles (ALCOA+)
Thanks & Regards,
Rahul Reddy
MARVEL InfoTech, Inc.
Direct: 732-802-6563
Desk: 732-802-6563 Extn 108
Fax: 732-875-0333
Email:- rahul@marvelinfotech.com
MBE – NMSDC – NYNJ