Hector G Perez Rodriguez

Perform sampling plans for all manufactured products.

• Perform batch record review.
• Perform SAP transactions.
• Participate in triage process.
• Perform oversight of process and procedures/GMP tasks.
• Compliance review of batch record elements and identification of discrepancies.
• Participate in internal plant audits.
• Work with operations to resolve basic compliance discrepancies.

• Perform and document Process and Facility Quality Audit in Manufacturing and Utility Areas according to established Procedures, cGMP and COMPANY Standards.
  
• Coordinate and conduct AQL Inspection to finish Products and monitor testing and inspection of materials and products to ensure finished product quality.
  
• Review of batch records, in-process documents, analytical data and other regulatory documentation to ensure compliance with corresponding Procedures, cGMP and COMPANY Standards.
  
• Perform SAP transactions to ensure good Inventory practices of Parenteral Manufacturing Materials according to stablished Procedures, cGMP and COMPANY Standards.
  
• Promotes safe environment with equipment and process designs that comply with all Company quality and safety procedures and national and local regulations.
• Audited activities of workers on production lines and shipping and receiving.

• Sterilization (SOP) of portable tanks and CIP (cleaning) /SIP (sterilization) of fixed buffer tanks and transfer lines.
• Follow Standard Operating Procedure (SOP) and Work Instructions to perform Formulation Process (protein concentration, Pool & Mix and Fixed Formulations), buffer preparation, and media preparation assuring product quality
• Sample collection and sample management.
• Use of LIMS to initiate and keep track of sample Chain of Custody.
• Perform material transactions and cycle count using SAP system.
• Use EBR to Contemporarily document processes.
• Follow aseptic technics to assure product integrity.
• Perform batch record revision, use and installation of aseptic connections.
• Ensure production records and testing result are complete, accrue, following cGMP requirements.
• Utilized problem solving skills to identify and resolve production issues quickly.
• Monitored process operations to comply with specifications.
• Conduct basic troubleshooting.

• Participate in product design reviews to provide input on functional requirements, product designs, schedules, or potential
• Problems.
• Review product documentation to ensure accuracy, compliance or completeness.
• Plan test schedules or strategies in accordance with delivery dates.
• Document defects and report defects to senior management.
• Prepared detailed reports summarizing findings from inspections or investigations.
• Reviewed engineering drawings and specifications prior to manufacturing start up.
• Trained personnel on proper use of testing instruments, safety protocols, and other related topics.