Experience

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  Epson precision philippines, inc.

  Jan 1998 - Jan 2004

  • Supervised Quality Assurance engineers in handling daily tasks.• Interfaced with members of Engineering and Production department to provide input on Quality Compliance issues.• Prepared technical documents for the validation of process equipment and coordinated execution of the documents within the manufacturing department• Approved controlled documents such as Product Drawings, Standard Operating Procedures (SOPs), Quality Control Charts, Packaging and Visual Inspection Standards.• Performed approval of new and in-process products, raw materials and packaging standards.• Coordinated development, issues and gaps in other area, and communicated the information to the group.• Maintained quality systems such as Incident Reports, Customer Complaints and Out-Of- Specification Reports. • Investigated and analyzed customer complaints and out-of-specification products and evaluated Root Cause Corrective Action (RCCA) program.• Performed internal quality audits and assisted ISO 9000 and ISO 14000 auditors on plant inspection. Show less

  • Engineering and Quality Assurance Assistant Supervisor

    Jan 2002 - Jan 2004

  • Engineering and Quality Assurance Engineer

    Jan 1998 - Jan 2002
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  Biovail corporation

  Mar 2007 - Jan 2011

  Validation / engineering compliance associate

  • Completed validation protocols for equipment, facilities and utilities• Planned and executed validation programs: (1) equipment installation qualification and operational qualification (2) facilities validation (3) utilities validation.• Coordinated execution of validation projects with Engineering, Quality Control and Production Departments.• Collated and evaluated test results for compliance to established specifications• Modified validation plan as required and prompted resumption of validation exercise as required.• Completed validation reports• Interfaced with members of Maintenance/Engineering department to provide input regarding quality Compliance issues.• Performed investigation on all deviations encountered during qualification process. Show less

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  Valeant pharmaceuticals

  Jan 2011 - Aug 2016

  Supervisor - validation

  • Develops and streamline validation procedures and strategies by researching best practice in accordance with site SOPs and policies.• Develops, reviews and approves validation deliverables such as Validation master plans, equipment, facility and utility qualification protocols, computer validation protocols, spreadsheet validation protocols, summary reports, discrepancy reports, traceability matrices and periodic review reports. • Manage validation projects deliverables through the application of basic project management principles including planning, scheduling, resources, timeline and reports.• Evaluates and supports the acquisition of new equipment with product transfer or continuous improvement efforts by collaborating with manufacturing and technology transfer groups.• Lead engineering studies by applying fundamental engineering skills to create new methods of operating or processing existing and new systems.• Prepares engineering deliverables such as Requirements documents, Enhance Design Review and Annual Product Quality Reports for manufacturing and packaging systems.• Ensures validation documentation is in compliance with good manufacturing practices (cGMP) and regulatory requirements.• Supports cGMP regulatory inspections and site investigations in validation/engineering related fields.• Conducts skill profile audits, reviews results with the group & develops training plan.• Interfaces with members of Maintenance & Building Operator’s group to provide input regarding quality Compliance issues.• Provides vision and guidance to employees in the area of occupational health, safety and wellness. Show less

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  Emergent biosolutions

  Aug 2016 - now

  • Lead validation projects which includes development of validation strategies, estimation of validation timelines and resources requirements, generation, approval and implementation of project validation plans, development of robust and efficient validation protocols and reports (FUE qualification, cleaning validation and process validation) for new and existing processes.• Manage the deliverables of validation projects through the application of basic project management principles including planning, scheduling, resources, timelines, budget and reports.• Works with cross functional teams in the development and execution of validation activities associated with new equipment, processes or system upgrades.• Participates in project activities including design of systems and equipment to ensure that they comply with applicable regulations & International Standards.• Provides technical input into all phases of the validation lifecycle from design phase through to the commissioning and qualification execution phase, through to maintenance and retirement phase.• Reviews and approves documents, i.e. protocols and reports, prepared by the validation team, other departments and contractor organizations as required. • Resolves and assists in the closure of deviations initiated during validation activities or as related to critical process parameters.• Assists in the implementation of any existing Validation program to ensure continued compliance to the regulations. Show less

  • Acting Manager, Quality Assurance

    Dec 2021 - now

  • Specialist, QA Validation

    Aug 2016 - Dec 2021