Emir Hadzovic Email & Phone Number

Somerset, New Jersey, United States

• Provided ITQA oversight for GxP Enterprise Business and Quality Systems, validation activities inclusive of documentation (Validation Plans, Specifications, Testing Protocols, and Summary Reports)
• Provided and executed a risk-based approach to ensure records and systems adhere to national and international regulatory guidelines on Electronic Records, Electronic Signatures and Data Integrity (e.g., FDA 21 CFR.
• Reviewed/approved IT change management documentation and authorizing system use upon verification that requirements are met
• Delivered high quality and consistent independent reviews across the IT Organization in alignment with ITQA Computer System Validation (CSV) and risk policies, procedures, standards and guidance documents related to.
• Support internal, external audits (e.g., Vendor Qualification Assessment and regulatory audits and inspections) as needed
• Maintain up-to-date knowledge and understanding of quality system requirements (using/creating SOP) as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies.

Somerset, New Jersey, United States

• Prepare legal documents for Production Change Requests (PCRs) to ensure quality assurance in major company changes within both store and corporate systems
• Collaborate with a team to ensure that PCRs went through the DocuSign in daily meetings
• Analyze Change Requests using historical data to approve or deny
• Ran vulnerability scans through Greenbone Security Assistant with OpenVAS Scanner
• Upload spreadsheets for vulnerability scans to Wrike review for each quarter
• Well versed in risk management and SOX compliance

Bachelor'S Degree, Information Technology

Associate Of Science - As, Information Technology