RAMSIS AZER

• Team leader for electronic (paperless) qualification of process equipment, HVAC, CSV and utility systems using ValGenesis validation software
• Review and approve protocols, deviations and final reports
• Review and approve SOPs
• Lead FMEA studies.

• Review executed protocols, deviations and final reports for manufacturing equipment, HVAC, clean and plant utility systems
• Lead FMEA studies on USP Purified Water system
• Create templates for qualification protocols, final reports to improve consistency across lifecycle documents.

• Team leader for the commissioning and qualification of Botox manufacturing system
• Equipment train included fermenters, purifications and CIP systems
• Write and execute IQ/OQ protocols, resolve deviations and produce final report
• Lead CIP and SIP cycle development
• Team lead for updating, creating SOPs for a new Drug Substance.

• Manage CQV activities for Shenzhen, China facility
• Create a validation strategy for Regional Service Centers worldwide
• Develop a training program on Validation Best Practices
• Responsible for qualifying Device Decontamination procedures.

• Manage updating activities for Process Specifications and SOPs to an FDA compliant state
• Perform SPC, FMEA and Risk Assessment studies
• Establish operating parameters of assembly and filling lines to produce consistent product quality
• Write, review and execute qualification protocols to confirm operating parameters ranges.

• Manage CQV activities for the new reagent facility
• Write/review IQ/OQ/CSV protocols for utilities, HVAC and process equipment
• Supervise and coordinate junior validation engineers’ activities.

• Manage SOP updating activities to ensure compliance to 21 CFR Part11
• Identify and remediate gaps in manufacturing Batch Records and manufacturing audit trail
• Implement audit trail functionality to equipment control software
• Write and execute CSV protocols
• Complete CAPA reports, change control, deviation resolution and final reports.

• Update quality systems documents to current standards (URS, maintenance and manufacturing SOPs/Batch Records)
• Identify and implement Manufacturing Process Improvements for fermentation, Lysis and downstream processes
• Write and execute cleaning validation protocols for upgraded upstream manufacturing system
• Complete CAPA, FMEA reports, change control, deviation resolution and final reports.

• Installation of a GMP Cold Room for manufacturing ($500K)
• Define scope, resources and budget for the installation of a new GMP cold room for manufacturing
• Design, procurement and installation of the cold room
• Prepare RFP document for cold room installation, bid analysis and GC selection
• Author lifecycle documents, review and approve executed protocols
• Author IQ/OQ/CSV for the new cold room
• Construction management, startup and qualification
• Bulk Chemicals Storage and Distribution Systems (4 MM)
• Define scope, resources, and budget with internal cross-functional teams to implement the bulk chemicals storage and distribution systems
• Develop VMP and Project Plan for the storage and distribution systems
• Produce IQ/OQ/CSV for each chemical system, which included CIP chemicals, IPA, Waste IPA collection and Methylene Chloride
• Develop P&IDs for all systems
• Develop the sequence of operation and automation strategy, produce Automation Functional Specification
• Prepare RFP documents for general contractors, Bid analysis and GC selection
• Construction management, start up and validation.

• Prolacta Bioscience – Authored URS, IQ and OQ documents for various processing equipment
• Manage validation engineers and client’s technicians during protocol execution
• Neutrogena - Los Angeles CA - Lead the upgrade of a fill finish packaging line with high-speed equipment (120 ppm)
• Equipment selection, installation and qualification (FAT, IQ/OQ/PQ).

• Manage teams during execution of validation protocols, author protocols for a variety of processing systems and equipment, business development
• TEVA Parenteral: Manage teams during execution of qualification activities of a WFI generation, Storage and Distribution system
• Author qualification protocols and Automation Functional Requirements
• Gilead Sciences: Commissioning and qualification of an aseptic filling system for a pharmaceutical client in the LA area
• The system included vial washers, Depyrogenation tunnel, vial filler and Lyophilizer Auto-Loader
• Author commissioning and qualification protocols as well as automation functional specifications
• Illumina - San Diego, CA: Produce and execute validation protocols for plant utility systems (N2, E-Generator, CCA), stand-alone fridges and walk-in cold rooms and freezers.

Vacaville, Ca

• Perform control qualification (CQ) functions on Honeywell's MCS Experion and POMSnet softwareReview and approve software testingStart up of manufacturing systems (CIP, SIP, Upstream, Downstream)
• Track software change control
• Perform production recipe testing for accuracy and data integrity
• Resolve and close deviations encountered during testing
• Write Validation Summary Reports for tested systems

Hillsboro, OR

• Author IQ and OQ protocols for MCS hardware according to established URS and FS
• Author testing protocols for MCS end to end integration to show compliance with CFR21 Part 11
• Baxter Biosciences, Glendale, CA – Start up and commissioning of several blood fractioning trains
• Equipment included Buffer and precipitation vessels, large volume filter presses and centrifuges.