Develop qualification strategy, author and execute qualification protocols for a Biconical Bins Blender and for an IMA Coating Pan meeting applicable regulatory and safety requirements as well as customer expectations. Also, generate and resolve any discrepancy observed during protocols execution and completion of Summary Reports. Review of Standard Operating Procedures for the operation, cleaning and maintenance of the qualified equipment.

Provide Quality oversight, guidance and support to the Facilities, Utilities, Maintenance and Engineering (FUME) areas at a solid dosage pharmaceuticals manufacturing facility. Approval of Facilities, Utilities and Equipment Qualification Life cycle Documentation. Responsible for the compliance aspects of the Maintenance and Calibration Programs. Review and approval of Investigations and Change Controls. Approval of Engineering Drawings and P&ID’s. Compliance support to Six Sigma Projects (Operational Excellence). Perform internal and suppliers audits. Qualified as originator, executor and approval for TrackWise system (Change Control and Events modules), Regulus and MAXIMO systems.

Developement and execution of Commissioning and Qualification documentation and protocols for Facilities, Utilities and Pharmaceutical Products Manufacturing Equipment.Development of Standard Operating Procedures (SOP) and training material for equipment, facilities and processes for Pharmaceutical Products Manufacturing operations. Generation of Criticality Assessments and Risk Assessments.CAPAs generation and implementation.Metrics generation and reporting.Annual Product Review and Periodic Validation Review data gathering and report generation.Preventive Maintenance job plan generation for utilities, facilities and manufacturing equipment.As Built Drawings generation.

Creation and development of technical documentation for systems, equipment and processes. Generate Standard Operating Procedures (SOP) and Training Materials based on design documentation, manufacturer specifications and physical inspection of utilities systems and process equipment.