Puerto Rico
Chemical Engineer with over 20 years of experience in the pharmaceutical and biotechnology industries. Supervisory experience and experience in different areas such as: manufacturing operations, equipment and computer system validation/commissioning, utilities, maintenance, quality assurance, technical services, new product introduction, CAPA, change control, cGMP and FDA requirements. Also experienced conducting internal and external audits. Green belt/six sigma.
I work for Lilly del Caribe, Carolina, as a Computer System Quality Assurance representative. My duties include: Review and approve documents related to the computer validation life cycle (Validation Plan, Validation Report, Requirements, Security Plan, System Overview, System Configuration, Test Plan, etc…). Review and approve SOP’s related to regulated computer systems. Review and approve changes related to regulated computer systems. Participate and conduct audits to different areas to assure compliance with company and regulatory requirements. SAP Quality Data Steward-Provide general support to the Computer System Quality (CSQ) area. Also provide support for SAP application, creation and maintenance of Master Data, BOM and recipes. Generate DSD document for Compliance Suite. Create Installation Verification Instructions (IVI’s) and execute Test Scripts for Compliance Suite application.
I work for Lilly del Caribe, Carolina, as a Computer System Quality Assurance representative and as a Quality Engineer. My duties include: Review and approve documents related to the validation life cycle (Validation Plan, User Requirements, Design Qualification, etc…), for computers and equipment. Review and approve SOP’s related to regulated computer systems. Review and approve changes related to regulated computer systems and equipment. Participate and conduct audits to different areas to assure compliance with company and regulatory requirements.