Adolfo Ramirez Email & Phone Number

San Diego, California, US

• Oversight of CSV projects on 4 company sites including 2 new facility start-ups.
• Direct and coordinate validation activities of contractors, vendors and service providers.
• Act as IT Quality Systems SME during audits.
• Review and improve CSV procedures and business processes.
• Serve as liaison with IT and Automation Engineering departments to achieve compliance.
• Create and execute Data Integrity remediation plan using GAMP maturity model.

Gainesville, Georgia, US

• Recro (now Societal) acquired IRISYS
• Planned and successfully performed domain change of all servers and GxP systems to new parent company domain including SSO & LDAP enabled applications.
• Harmonized IT Policies and Procedures company-wide including GxP SOPs.

• Validation and compliance audits.
• Pharmaceutical serialization.
• CSV SME.

• Computer Systems Validation per 21 CFR Part 11 requirements and GAMP5 guidelines.
• IT audits from NIH, FDA, DEA and clients.
• eCTD IND applications.
• Laboratory systems and applications (Agilent, AB Sciex, Cape Cod, Shimadzu, Thermo Scientific).
• Electronic Quality Management System.
• IT security training.

• IT consulting to a variety of small businesses.

• Store management reporting directly to company owner.

• Back-end coding of websites (PHP, MySQL, Apache).

• Implemented, maintained and serviced IT solutions for clients.

• Windows Server network with 40+ workstations.