Rex Serrano Email & Phone Number

Highly knowledgeable and skilled Licensed Chemist (#3348) Experience in Quality, Regulatory Compliance, and Validation. Expert with SAP (Quality SCM & ECM), Trackwise, EPIC, Insight,LIMS, Project Management, Cleaning, NDA, CMC submissions. Investigations/CAPA, Root cause, Statistical Analysis, Qualifications, Change Management, Computer Validation (CFR 21 Part 11), Technical Writing. Fully bilingual Key AccomplishmentsRegulatory Affairs /Compliance• 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 areas.• Participated in over 15 Regulatory/FDA Inspections and Internal/Corporate/Divisional audits. • Corporate Site Certification for CMC Regulatory Submissions.• Managed regulatory activities for site products and new markets.• Assured compliance posture within the quality GMP’s standards for all validations at manufacturing, packaging, laboratory.• Report on an Annual Review to CMC activities impacting filing as change control (i.e. process) Quality• Trained employees and pursued growing and cross trainings.• Prepared stability, annual review and internal reports.• Managed the start-up of a major chemical/microbiology laboratory.• Performed productions schedules while maintaining QA releases on time and with a Customer Service Level, Quality metrics,Scorecard.• Audited, certified vendors and suppliers. Handle transfer methods.• Lean Six sigma QA to reduce documentation errors, deviations and batch record release process to improve site performance• Evaluate and Approve Trackwise for Complaints/Audits/Change Control and non-conformance.Validation• Validated/Qualified cleanings, equipment, instrument, utilities, manufacturing, packaging, auomation (Delta V,Provox)

Listed skills include Pharmaceutical Industry, Project Management, Leadership, Microsoft Office, and 41 others.