Robin Roxas Email & Phone Number

Independent Pharmaceutical Consultant providing support and guidance in the API, Sterile filling and injectibles, pharmaceutical manufacturing, packaging and engineering operations.The Quantic Group, Ltd• Provide management and shop floor guidance as SME and support to be compliant with cGMP Review daily production documents for accuracy and completeness.• Provide Operation’s task review, identify steps needed to accomplish each item and coordinate meetings to drive objectives to completion.• Support in the preparation for an FDA and EMA audit and simulate the discussions in preparation with auditors.• Review and critique validation documents.• Support review of investigations, Deviations and CAPA plans. Utilize root cause analysis investigative tools (i.e. KT, FMEA) to pursue resolution and PQ protocol development and execution.• Design cGMP compliant repackaging operation facility.• Support review of investigations, Deviations, CAPA plans and Change Control documents.• Support Operations restart with phased-in steps in partnering and mentoring the management and Quality personnel. Develop Restart Protocol and specific Product and/or Process Plans to assist in gap assessments. Progress mentoring Shop Floor and Quality Systems’ support to completion of Restart.• Support site remediation on Change Control, Gowning and Production Control (Batch Records) Systems. Provide suggestions on improvements to procedures and documents.• Clients supported:o Novartis Consumer Healtho GSKo Gilead Sciences, Inc.o Pfizero Emergento Welldyne, Inc, Lakeland, FL• Source Pharmaceutical filling and labeling equipment for repackaging Unit of use and Unit Dose prescription solid dosage drug products.• Develop and support writing of Standard Operating Procedures for the Repackaging Operation.• Develop and support writing validation plans for the Repackaging Operation.• Develop URFS facility requirements for a cleanroom re-packaging operations area.

·Manage the Engineering and Maintenance department, responsibility includes Capital Projects for facility improvement and packaging automation. Also worked as a consultant during the past nine months in the same role.·Analyze operational opportunities and pursue process improvements.·Review and improve on cGMP documentations, improve on Equipment Validation, initiate use of Purchase specifications and User Requirement and Functional Specifications, and streamline the Preventive Maintenance System and Parts Inventory tracking in SAP.·Provide guidance and technical support to the Operations in improving labor utilization, lead efforts in Engineering and Maintenance departments in vendor sourcing, supply availability and pricing & negotiations, and support the OEE (Over-all Equipment Effectiveness) initiative on requirements and expectations.·

Nj

· Areas of responsibility include ensuring maximum performance from the mechanical staff, assisting employees to troubleshoot equipment and systems, maintaining equipment and product quality and efficiencies, equipment rebuilds, providing training, providing timely and accurate communications, ensuring all local and national regulations are followed such as cGMP, OSHA safety, environmental, etc.,· Manage the maintenance of stockroom spare parts and change parts inventory control,· Maintain operational documentation such as set up sheets, set up procedures, preventive maintenance, corrective work orders, calibration, housekeeping, change control, SOPs, pass down logs, batch records, etc.,· Pursued the installation and implementation of OEE system to improve equipment efficiency performance.

Nj

·Areas of responsibility included development, implementation and deployment of Level II Quality Standards across all FDA and non-FDA regulated sites worldwide. The operational areas involved were: Sterile and non-Sterile Production, Labeling & Packaging, Validation, Critical Systems, Process Equipment, Equipment Qualification, Calibration and Maintenance Systems.·Adviser in the corrective action plan and audit preparation at the Puerto Rico facility sites.·Quality Systems Expert and Conference Facilitator with the FDA regulated sites in meeting the cGMP Workplan development and commitment, therby completing all requirements with the Consent Decree. ·Worked with consultants in the remedial actions taken to assist FDA audited facility sites.

Hobart, Ny

• Areas of responsibility included Liquid and Solid Dosage Manufacturing, Bottle/Pouch/Blister Packaging, Capsule Sealing, Clinical Packaging, Engineering, Maintenance and Materials Management (Warehousing, Shipping, Purchasing, Planning and Scheduling).• Directed/managed Manufacturing and Packaging Plant Operation of over 200 employees. Interfaced with Regulatory Affairs, Quality Control, Quality Assurance, Research and Development, Validations, Engineering, Cost Accounting, Finance, Marketing, Scheduling, Purchasing, and other manufacturing department personnel to coordinate and accomplish company objectives. Responsibilities included:o Start-up and validation of new manufacturing facility. Completed product transfers in a timely manner.o Implemented departmental labor reporting system for efficient labor utilization. Assisted in product costing.o Pursued employee training programs on machine operations, current Good Manufacturing Practices, safety and standard operating procedures.o Worked on process improvements resulting in more consistent assay and dissolution results.o Customer interface with contract and clinical manufacturing business.o Updated all products’ manufacturing process validations.o Equipment and facility improvements in engineering, capital justification, purchasing, installation, operational and process qualifications.o Worked with new product development projects and formulations up to scale-up production batches.o Initiated plant and equipment calibration program.o Supported the sales business with new and existing customers.• Managed Materials Requirement Planning program to effectively reduce inventory, improve material availability and utilization. Created a warehouse locator and improved materials tracking system.• Pursued improvements on computerized inventory control and customer order reporting system.

Fort Lauderdale, Fl

• Responsible for packaging vitamins, over-the-counter drugs and prescription drug products.• Managed an operation of over fifty (50) employees from Warehouse Receiving, Production Planning, Scheduling, Packaging to Shipping of finished goods to various distribution centers in the US.• Implemented computerized system for product inventory, shop floor control, capacity planning and production performance reports.• Developed employees’ training program for machine operations, Current Good Manufacturing Practices and Safety.• Implemented the Unit Dose Thermoforming operation for prescription and controlled drug products.• Justified the in-house manufacturing and packaging of liquid product.

Kenilworth, Nj

• Managed a department of twenty (20) packaging mechanics in an unionized environment. • Responsible for up to twenty five (25) packaging lines involving various packaged products.• Established procedures to standardized mechanical training and to upgrade equipment.• Supervised the installation of packaging equipment.• Implemented downtime reporting system to specify and improve the nonproductive areas.