Manuel Rosario-Alomar
Cqv Validation Lead- @Zifo
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WORK HISTORY
Cqv Validation Lead- @Zifo
Albany, NY, US
Ensured strict compliance with global regulatory requirements (e.g, FDA, EMA, ICH) associated with all QC activities, including commissioning, qualification, validation, and decommissioning of laboratory instruments.• Led the end-to-end commissioning and qualification (IQ/OQ/PQ) of new QC laboratory instruments—including analytical balances, HPLCs, GCs, UV-Vis spectrophotometers, dissolution testers, and microbiological systems—ensuring data integrity and seamless integration into the laboratory workflow.• Developed and executed comprehensive validation master plans (VMPs), system requirement specifications (SRS), risk assessments, and qualification protocols (IQ/OQ/PQ), adhering to regulatory and cGMP guidelines.• Managed the decommissioning of legacy QC equipment by overseeing data backup, system retirement procedures, and documentation archiving, ensuring compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).• Collaborated cross-functionally with Quality Assurance, IT, Engineering, and instrument vendors to ensure smooth execution of validation and decommissioning projects with minimal operational disruption.• Conducted impact assessments to identify regulatory and operational risks associated with equipment replacement or removal, and implemented risk mitigation strategies to maintain data integrity and product quality.• Maintained complete and traceable documentation through robust Change Control, Corrective and Preventive Action (CAPA), and deviation management processes.• Provided technical training to QC personnel on the use, maintenance, and documentation of newly commissioned instruments, fostering a culture of compliance and operational excellence.
EDUCATION
University of Puerto Rico-Mayaguez
Graduated Shcool, Biochemistry, Biophysics and Molecular Biology
Inter American University of Puerto Rico, San German Campus
Bachelor of Applied Science (B.A.Sc.), Chemistry
ABOUT MANUEL ROSARIO-ALOMAR
I am Manuel Rosario-Alomar, QA Validation Lead. With over 13 years of experience in the Biopharma and Radiopharma industries, I have held diverse roles and developed a strong expertise in the API sector. I have a proven track record in leading the development and validation of analytical methods for the release of radiopharmaceutical products, ensuring compliance with cGMP and regulatory requirements.My background includes expertise in radiopharmacy, biochemistry, biophysics, and molecular biology, with several publications and patents related to amyloid fibrils and hydrogen sulfide. I am also proficient in various laboratory techniques, including HPLC, LC-MS, Raman spectroscopy, and fluorescence. I am passionate about enhancing the knowledge and skills of the site QC staff, balancing priorities, and solving complex problems.I enjoy working with dispersed teams and collaborating with cross-functional partners to deliver high-quality products that improve patient outcomes. Outside of work, I enjoy playing basketball and spending quality time at the beach with my family.
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