Rex Serrano Email & Phone Number

San Juan, Puerto Rico

Juncos, Puerto Rico

Provide expertise in chemistry, manufacturing and control (CMC) regulatory requirements.Manage the preparation of CMC sections for new marketing applications, and post-market supplements.Manage product deviation investigations, participate in site change control teams and serve as the CMC point of contact for these activities.Support Global RA CMC regulatory strategies for product specifics as a representative.Manage the generation of facility and GMP related document to support… Show more Provide expertise in chemistry, manufacturing and control (CMC) regulatory requirements.Manage the preparation of CMC sections for new marketing applications, and post-market supplements.Manage product deviation investigations, participate in site change control teams and serve as the CMC point of contact for these activities.Support Global RA CMC regulatory strategies for product specifics as a representative.Manage the generation of facility and GMP related document to support emerging market registrations. Manage and prepare DMF and CMC sections of annual reports of minor changes for specific products and sites. Interact with Regulatory Amgen Global and Regional representatives. Also, support activities for the SMF. Show less

Barceloneta, Pr

Supported all quality activities related to Chemical/Pharmaceutical plant. Supervise four co-workers.Reviewed investigations/atypical/complaints impacting manufacturing and laboratory.Manage qualifications, validations (cleaning/equipment/process), change control (Trackwise, SAP). Define standards and improvements and reviewed outcome of performance goals to set future targets.Worked in initiatives to reduce documentation errors, deviations (number and closed time) and other… Show more Supported all quality activities related to Chemical/Pharmaceutical plant. Supervise four co-workers.Reviewed investigations/atypical/complaints impacting manufacturing and laboratory.Manage qualifications, validations (cleaning/equipment/process), change control (Trackwise, SAP). Define standards and improvements and reviewed outcome of performance goals to set future targets.Worked in initiatives to reduce documentation errors, deviations (number and closed time) and other activities to improve site performance/time frame; including Lean QA as batch record release process. Managed all the Visual Boards on the area for the purposes of demonstrate the actual status of all lots activities/status pending and needed to then follow up it. Maintained QA release for productions schedules. Provided all regulatory information. Show less

Barceloneta, Pr

Attended all related issues of Regulatory/Compliance to site products, and introduction of new products. Annual Product Review Report, complaints, CAPA, Investigations, process changes, etc.Validations for Manuf./Laboratory/Utilities (Water systems), Cleaning Validation, Computer validation. Supported NDA activities, Quality/Corporate/Internal/FDA/Suppliers Audits and Suppliers Quality Issues. Statistical analysis including Shift and Trend statistical evaluations. Developed, approves… Show more Attended all related issues of Regulatory/Compliance to site products, and introduction of new products. Annual Product Review Report, complaints, CAPA, Investigations, process changes, etc.Validations for Manuf./Laboratory/Utilities (Water systems), Cleaning Validation, Computer validation. Supported NDA activities, Quality/Corporate/Internal/FDA/Suppliers Audits and Suppliers Quality Issues. Statistical analysis including Shift and Trend statistical evaluations. Developed, approves department procedures/policies. Participate on the Vendor Certification and Reduce Testing Programs.Compliance/Regulatory activities, Annual Product/Stability Reports, Qualifications, Investigations, CAPA.Supervised all the laboratory functions/activities. Implementation of the Trackwise for Complaints at site. Coordinated activities on validations for the laboratory/manufacturing and packaging (i.e. Network). Show less

Bachelor Of Science (Bs), Chemistry

Medical Tecnologist, Chemical & Microbiology Studies

Master'S Degree, Environmental Studies