Proven
Results
- Plant Maintenance Shutdown Management and Remediation Plan Execution successfully completed before timeline due date without impact to start up operations.
- Implementation of a line in record time (less than 6 months) managing all aspects of the projects including from project management to equipment qualification and computer system validation.
- Full Qualification Cycle for Manufacturing Area; formulation, filling and Packaging, Installation, Commissioning and FDA and Local Government Agencies Approval.
- Responsible for start-up, commissioning and CSV consulting, development execution of expansion projects.
- We deliver results by being an integral part of the team assisting to all project meetings as an integral part of the team since its inception.
- Full Lab Class 10 Qualification, Commissioning, Installation/Qualification and FDA and Local Government Agencies Approval of New Products.
- Successful implementation of regulatory requirements: Grade D Environmental Monitoring requirements, Disinfectant for manufacturing areas cleaning (selection and validation) Compressed Air System Monitoring program, among others.
- Business Continuity Plan Development and Execution.