Puerto Rico
19+ years field experience in a regulatory environment: Pharmaceutical / Biotechnology / Medical Device industry. Action-driven and results-oriented in Quality, Technical Services, Validations, Compliance, New Product Introduction (NPI), Technology Transfer, Engineering Capital Projects and Project Management areas including under a Consent Decree and Warning Letter environment. Experience in development, review and approval of validation documents, quality systems, compliance, and Risk and Information Systems management. Responsible for validation life cycle activities: IQ, OQ, PQ, Reports; process optimizations, audits, investigations, statistical analysis, among others. Easily adaptable to change and with a focus on continuous improvement initiatives and development within organizations. Possess a balanced mix of both business acumen and technical expertise and bilingual in English and Spanish.
Developing regulatory commitments answers and new procedures in alignments with corporate guidelines and regulatory requirements. Support to Quality Risk Management (FMEA Risk Assessments) activities as area SME. Gathering and interpreted data (reliability, quality, qualifications, etc) to assure the manufacturing major equipment compliance - Equipment Periodic Review. Developing technical reports.
Support Data Integrity initiative compliance for Laboratory and Manufaturing systems.
Technical Transfer support - Oral Solid Dosage (OSD) New Product Introduction (NPI)
Technical Operations support