Rogel Roy Malsin Email & Phone Number

Pomona, California, United States

Project Manager | Project Management Office, Northeast Operations• Validation and Compliance: Played a key role in developing a repository of risk-based validation document templates based on the ISPE Baseline Guide, streamlining PSC Biotech's service offerings and standardizing validation for pharmaceutical equipment and processes.• CSV/CSA & SDLC Compliance: Managed SDLC compliance for Organon’s business technology projects, ensuring adherence to regulatory standards through structured processes and controls, while collaborating with stakeholders to align project objectives with compliance requirements.• CSV Spreadsheet Validation Leadership: Led a team in executing spreadsheet validation protocols, establishing standards for e-protocol execution, resolving deviations, and ensuring alignment with client and quality goals.• Risk Assessment: Conducted comprehensive risk assessments for systems slated for implementation, leveraging CSA principles to validate, test, and release software and infrastructure, safeguarding regulatory compliance.• Resource and Team Management: Oversaw resource allocation and conducted regular check-ins to monitor progress and address roadblocks. Created a skill matrix to assess team competencies in CQV, CSV, automation, management, and quality, optimizing resource deployment.• Project Coordination: Coordinated multi-workstream projects, delivering presentations, facilitating informed decision-making, and aligning goals with organizational standards.• Resource Optimization: Managed project budgets and schedules, optimizing resources to enhance cost-efficiency and meet quality and regulatory benchmarks.• Technical Proficiency: Skilled in MS Project, Power Automate, and Excel VBA for resource management and process optimization.

Mandaluyong, National Capital Region, Philippines

Coating Department Team Leader• Leads and supervises a team of machine operators and casual personnel to ensure quality production of film-coated and sugar-coated tablets in compliance to GMP and PIC/S guidelines, and regulatory requirements.• I have been involved in a team for the validation of a new purified water system complaint to USP-NF guidelines for purpose of general pharmaceutical production. Also, I have created procedural documents and work instructions to ensure consistent purified water quality and consistent equipment uptime• Engaged in the Total Productive Maintenance (TPM) team in the creation of machine FMEA for all machines of the manufacturing plant in the paradigm shift to proactive maintenance initiatives.

Mandaluyong, National Capital Region, Philippines

Packaging Department Team Leader• Leads and supervises a team of at least 4 machine operators and 20 casual personnel in the packaging department to ensure quality and timely delivery of packaged finished goods in compliance to GMP and PIC/S guidelines, and regulatory requirements.• I have resolved consumer product complaints and quality deviation reports using root cause analysis tools like 5 Whys, Fishbone diagram, FMEA, etc.• The team and I have conceptualize and implemented innovative and effective corrective and preventive action projects for the goal of cycle-time reduction (2-hour machine changeover reduction, and machine rate improvement), mistake proofing (visual standard packaging guides), and cost-reduction (packaging BOM reduction).• I was involved in validation of machine computerized systems, and validation of packaging process for new equipment and products.• I have created various procedural documents for packaging process and work instructions, and packaging machine equipment manuals.• Lead team that won Kaizen of the Year awards for 2 consecutive years.

Ncr - National Capital Region, Philippines

Production Scheduler• I have created weekly production schedules for the production runs for at least 7 granulation workcenters, 5 tabletting workcenters, 2 capsule filling workcenters, 11 coating workcenters, and 6 packaging workcenters for Unilab Manufacturing.• I have been involved in ensuring timely delivery and fulfillment of the monthly demand of ascorbic and ferrous products in coordination with planning, marketing, sourcing, and quality assurance departments.

Chungli City, Taoyuan, Taiwan R.O.C

Served as research intern which focused on the study of visible light photocatalysts for the treatment of industrial textile wastewater. Solely researched on the use of nitrogen-doped titanium oxide integrated in a slurry membrane photocatalytic reactor irradiated under visible light using LED. Experiment result show a maximum of 99% decolorization of a simulated textile wastewater using an RB5 dye.

Bachelor Of Science (Bs) In Chemical Engineering, Chemical Engineering

Activities and Societies: Served as Treasurer, and then as Business Manager for the Chemistry Society of Mapua. Member of Philippine.

Bachelor Of Science (Bs) In Chemistry

Activities and Societies: Chemistry Society of Mapua Philippine Institute of Chemical Engineers - Junior Chapter Mapua Institute.

High School

Activities and Societies: Lead a team involved in the documentation of important school events.Honorable Mention Awardee Service Award