Experience

Fits

• Validation Specialist

  • Apr 2014 - Present

  CSV to QC Laboratory equipment in compliance with client's procedures and policies.Computer Validation for manufacturing electronic batch records.CSV assessment for Electronic Records and Electronic Signatures in compliance with client's policies and directives following CFR Part 11 requirements. CSV to QC Laboratory equipment in compliance with client's procedures and policies.Computer Validation for manufacturing electronic batch records.CSV assessment for Electronic Records and Electronic Signatures in compliance with client's policies and directives following CFR Part 11 requirements.



MOVA / Patheon

• Chemist/Instrumentation Specialist/ QC Supervisor

  • 2002 - 2008

  As Chemist: Raw Materials, Finished Product & Stability Samples analysis and testing according to USP/EP requirements. As Instrumentation Specialist: Execute laboratory equipment PM & calibration according to written procedures. Computerized Systems maintenance and backup. Develop and execute Empower Software Installation and Validation activities (Empower System Administrator). Develop and execute laboratory equipment qualifications.As QC Supervisor: Supervise QC Analysts (for finished product and stability samples testing) and QC Instrumentation group. Create/revise SOP's and Forms. Conduct investigations for out of specifications and/or out of trend samples results and calibration failures. Participate in clients' and regulatory agencies inspections. Manage corrective/preventive actions based on investigation reports and observations during audits. Manage Capital Projects for QC Instrumentation purchase and validation.