Sajid Azhar
Contractor Consultant @Independent Consultant
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WORK HISTORY
Contractor Consultant @Independent Consultant
Dallas, TX, US
EDUCATION
Osmania University, India
Bachelor of Science (BS), in Chemistry, Genetics & Zoology
ABOUT SAJID AZHAR
Seeking a challenging QA/RA Full Time Permanent or Contract/Consulting position. Please contact by email s•••••••@gmail.com A Senior Quality Assurance, Regulatory Affairs, Quality Engineering, Manufacturing, Clinical Programs, Compliance Activities, Management Professional with more than 10 years of experience and a successful record in the Medical Device, Diagnostic, Pharmaceutical & Cosmeceutical industries in various capacities. Specialties: Quality Systems, Regulatory Affairs • Quality Systems: ISO 13485, FDA QSR • Assist in Regulatory Submissions: 510(k) • Technical Files, DHF Project Assessment, Management and Documentation • Quality System Development • Complaints, CAPA, NCR, Product Recall • Domestic and International Consulting on QSR, ISO, MDD and CMDR • Internal and External Audits • Supplier Quality Qualification, Supplier Audits and performance of Supplier Audits • Risk Management • Responding to FDA 483 and Warning Letter • Create Quality System Documentation (Quality Manual, SOPs, and Procedures)
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