Experience

Leonie Agri Corp

• Philippines
• Farming
• 1 - 100 Employee

• Quality Assurance Manager

  • Aug 2016 - Present

  - Responsible for establishing the Quality Management System for the new Herbal processing facility. - Responsible for generating Protocols to be used in Commissioning and Validation activities. - Responsible for the development of a Site Master File and Validation Master Plan in close collaboration with the Production Manager. - Ensures that Commissioning and Validation are carried out for the new facility. - Responsible for the authorization of written procedures and other documents including amendments. - Responsible for daily quality operations within the department. - Ensures compliance to procedures and addresses non-compliance via the corrective and preventive action (CAPA) system. - Provides direction, scheduling and training of supervisors on systems, procedures and day to day activities. - Conducts routine internal audits of processes, systems and procedures. - Leads and facilitates cross-functional teams in order to identify effective corrective and preventive actions to improve process quality. - Generates, thoroughly evaluates and gives input to change controls and leads to its completion. - Oversees product testing, batch processing inspection, packaging inspection, environmental monitoring, plant hygiene and training with reference to the Standard Operating Procedures, HACCP, 5S and cGMP. - Responsible for the approval and monitoring of contract manufacturers and suppliers of materials. - Responsible for the retention of records such as Manufacturing Batch Records, Logbooks, Validation Protocols, Product Registration and other Quality related documents. - Ensures timely closure of audit items. - Drafts and revises SOPs as needed to ensure compliance and continuous improvement. - Conducts root cause analysis for any deviations generated at the facility during all phases of the production process. - Performs routine review of quality related documents and make necessary amendments as needed. Show less



Pascual Laboratories, Inc.

• Philippines
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Project Management

  • Jul 2015 - Jul 2016

  - Monitors project status and team performance. - Ensures that teams are working in line with established roles and responsibilities. - Maintains project management monitoring for all project related information including timelines, milestones, priorities. - Schedules the project in logical steps and budgeting the time required to meet deadlines. - Confers with the Project Management Team to discuss and resolve matters such as work procedures, complaints and construction problems. - Prepares and submits budget estimates, progress and cost tracking reports. - Ensures that the Steering Committee is informed on project status, risks and variations to the approved budget. - Develops effective project milestones, schedules and manage budgets. - Identifies and resolves issues that may jeopardize project schedules or improve project time. - Identifies and resolves resource conflicts between the Steering Committee and Project Management Team. - Facilitates team decision making and maintains an effective working relationship with plant operations, quality, regulatory and project teams. - Initiated and conceptualized the organization in coordination with the Human Resources department. - Recruits talent and manages headcount aligned with the approved organization plan and budget. - Develops, implements and sustains the reporting of metrics accurately demonstrating the performance level, value and accountability of the team. - Understands strategic imperatives to project success, innovative technology and costs. - Ensures appropriate expert input, review and approval of procedures, protocols, product and process master Sterility Assurance validation plans, investigations and final reports. - Maintains current knowledge of relevant Quality System Regulations and other regulatory requirements. - Ensures compliance with PICs/GMP standards for facility, systems and processes. Show less



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Deputy Supervisor

  • Feb 2011 - Jul 2015

  • Responsible for providing buffer support for use in manufacturing processes in mammalian cell culture and purification while strictly adhering to cGMP, environmental health and safety guidelines and regulations that apply. • Investigates and troubleshoots any process related problems in a timely manner and provides the necessary documentation. • Responsible for providing buffer support for use in manufacturing processes in mammalian cell culture and purification while strictly adhering to cGMP, environmental health and safety guidelines and regulations that apply. • Investigates and troubleshoots any process related problems in a timely manner and provides the necessary documentation.



Invida Pharmaceutical Holdings Pte.

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regional Technical/QA Executive

  • Oct 2010 - Feb 2011

  • Responsible for regional scientific and technical management. • Manages and implements regional Quality and Technical assignments. • Responsible for ensuring products produced, imported and distributed by the affiliates in the supply chain system are in compliance with quality and regulatory requirements and bring in measurable continuous improvement in all these efforts • Responsible for regional scientific and technical management. • Manages and implements regional Quality and Technical assignments. • Responsible for ensuring products produced, imported and distributed by the affiliates in the supply chain system are in compliance with quality and regulatory requirements and bring in measurable continuous improvement in all these efforts



SeerPharma

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation/QA Specialist

  • May 2009 - Sep 2010

  • Develops User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV) protocols of pharmaceutical, radiopharmaceutical equipment and HVAC systems. • Regulatory Analyst for the Global Product Conformance program of Wyeth Pharmaceuticals Singapore • Regulatory Affairs Coordinator for Pfizer Singapore • Develops User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV) protocols of pharmaceutical, radiopharmaceutical equipment and HVAC systems. • Regulatory Analyst for the Global Product Conformance program of Wyeth Pharmaceuticals Singapore • Regulatory Affairs Coordinator for Pfizer Singapore



Avon

• United Kingdom
• Personal Care Product Manufacturing
• 700 & Above Employee

• Processing Supervisor

  • Jul 2006 - Feb 2009

  • Manages production schedule and resources to meet production targets, quality standards and delivery deadlines. • Supervises plant operations and control of chemical processes such as Powder and Perfume processing in accordance to current Good Manufacturing Practices (cGMP). • Manages and resolves production related and operational issues. • Ensures proper processing equipment set up, operation and maintenance. • Develops Work Instructions (WI) on new equipment and facilitates training to associates. • Ensures that batch records and operating log books are correctly accomplished. • Performs routine equipment maintenance and calibration in coordination with the Engineering department. • Develops, updates and reviews Standard Operating Procedures (SOP). • Identifies areas for improvement in the existing processes and implements innovative projects founded on Lean/Six Sigma principles with the goal to increase operational efficiencies, minimize maintenance expenses and ensure a safe working environment. Projects: • Jetmill Project: Installation of a secondary Jetpulverizer milling system. The project successfully reduced queuing time of in-process bulk powders for milling by 50%. • Alcohol Batch Controller (ABC) Project: Automation of the hydro-alcohol processing. The project significantly improved dispensing accuracy of ethyl alcohol and water and allowed simultaneous processing of products in different work centers thus increasing productivity. ABC also enhanced compliance to safety standards by allowing the processors to control critical equipment remotely using a Human Machine Interface and by explosion-proofing all necessary devices. Show less



Interphil Laboratories

• New Products Manufacturing

  • May 2005 - Jul 2006

  • Leads the technology transfer of new pharmaceutical products in coordination with the concerned departments from feasibility up to product commercialization. • Facilitates in a Cross Functional Team for problem resolution related to new products and implements necessary actions. • Conducts feasibility studies, hazards and operability studies on new and modified process for new products. • Develops master Batch Manufacturing Records for new products. • Participates in all aspects of plant activities including providing technical leadership to operations personnel for process and unit operations understanding. • Conducts process and equipment validation in support with the validation managers. • Develops, reviews, updates Standard Operating Procedures in accordance to FDA/TGA regulations. Show less



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer

  • May 2003 - May 2005

  • Performs routine cGMP/HACCP audits for all areas covered under plant manufacturing facilities to ensure strict compliance to Global and Regulatory requirements. • Conducts process and equipment validation in coordination with the technical services department. • Investigates production deviations and ensures Corrective and Preventive Actions (CAPA) are implemented effectively. • Performs routine batch review. • Conducts supplier audits to ensure compliance to company standards and technical agreements. • Reviews test reports and ensure they are in constant state of regulatory compliance • Provides technical support on quality issues. • Develops training materials and provide technical training to new associates • Performs routine instrument maintenance and calibration. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Inspector

  • Sep 2002 - May 2003

  • Conducts routine supplier audits and issues Corrective and Preventive Actions (CAPA) as necessary. • Evaluates supplier performance and recommends improvement projects. • Responsible for the sampling and inspection of all incoming raw materials, packaging materials and finished goods according to the latest military sampling standards. • Performs chemical analysis using wet chemistry methods and analytical instrumentation. • Leads and participates in Right First Time (RFT), safety and continuous improvement initiatives. • Ensures all materials inspected and tested are in compliance with the standards and are properly documented in the Technical Data Sheet (TDS). • Encodes all necessary quality assurance transactions in the BPCS and JD Edwards. Show less

• Manufacturing Technician

  • May 1998 - Sep 2002

  • Responsible for the manufacture and packaging of consumer healthcare and ethical pharmaceutical products such as antibiotics, analgesics and anthelmintics • Responsible for the successful implementation of a new bulk storage system improving productivity in the consumer healthcare processing category.• Instrumental in the immediate and successful technology transfer of Glaxo Wellcome products into the SmithKline Beecham facility in coordination with the technical services group in the year 2000.• Initiated the enhancement of the ethyl alcohol storage facility maximizing tank capacity by as much as 10%.• Develops, updates and reviews SOPs. • Coordinates with the production planner to ensure flawless execution of the liquids manufacturing and packaging schedule. Show less



Warner Lambert

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Inspector

  • Feb 1997 - Jul 1997

  • Responsible for the timely sampling and inspection of pharmaceutical products as well as packaging and raw materials. • Performs in-process audits in the production line to ensure compliance to cGMP. • Prepares a Non Conforming Item Report (NCIR) to the process owner as the need arises for corrective and preventive actions. • Ensures the accuracy of batch manufacturing records both for pharmaceutical and consumer healthcare products. • Responsible for the timely sampling and inspection of pharmaceutical products as well as packaging and raw materials. • Performs in-process audits in the production line to ensure compliance to cGMP. • Prepares a Non Conforming Item Report (NCIR) to the process owner as the need arises for corrective and preventive actions. • Ensures the accuracy of batch manufacturing records both for pharmaceutical and consumer healthcare products.