John Painter Email & Phone Number

Product and Process Validation Program oversight of Saint-Gobain Life Sciences Biopharma Solutions manufacturing facilities encompassing:Products:- extruded tubing- molded components- bioprocessing bags- cell culture bags- filtration systems- assembled productsTransportation studiesShelf life studiesMaterial changes / modificationsProcess changesSupplier.

This position reports through the World Wide Corporate Quality Validation Manager, but directly supports all validation work functions of the OPEX (i.e. Operational Excellency) Corporate Group. This position provides support and oversight to the Operational Excellence Program/Group at Saint-Gobain Life Sciences and has reporting to her/him all OPEX.

• Responsible for the compliant validation of facility / equipment / processes to satisfy ISO, local, and any other applicable requirements, in support of qualification and application fit for use requirements to release.
• Ensuring that validations of new or existing equipment/product meet regulatory/ISO requirements and the end user's industry standards
• Supporting/reviewing software validation requirements
• Supporting/reviewing Engineering Change Order process
• Supporting project management / scheduling and work breakdown structure, as needed
• Providing Quality/Validation technical expertise and training, as needed

• Draft SOPs for new manufacturing facility. SOPs include microbiology and chemistry laboratory equipment SOPs, sterility testing, mycoplasma testing, bioburden testing, environmental monitoring, personnel monitoring.

Tampa/St. Petersburg, Florida Area

• Manage batch record auditors, on-line QA inspectors, and label technician
• Assign disposition for all raw materials, packaging components, labeling, labeling specifications, and finished products
• Write Quality Assurance related investigations (Non-Conformances, Deviations, Corrective Actions, and Preventative Actions) and track root causes
• Participate in weekly Material Review Board meetings
• Provide monthly metrics for Lot Acceptance Rate, Right First Time, and On-Time Release
• Assist with investigations for customer complaints

• Provide project leadership at single site / multi site manufacturing operations for client sponsored compliance projects requiring quality remediation due to regulatory consent decree or inspection observations.
• Perform gap analysis between approved validation criteria, standard operating procedures and master device records / master batch records.
• Redesign quality documentation systems such as batch records, device history records and standard operating procedures to compliance with applicable regulations and standards, approved validation criteria and client.
• Draft and implement quality documentation style guide to simplify and standardize batch record, device record and work instruction documentation.

• Serve as Quality System Management Representative in absence of Quality Director.
• Responsible for the Quality Management System (QMS) for compliance to medical device Quality System Regulations (QSR) and pharmaceutical Good Manufacturing Practices (GMP).
• Provide and set the strategic direction including objectives and measurable goals for the organization as it relates to the quality system.
• Coordinate and lead internal quality system management reviews.
• Coordinate and lead notified body audits.
• Manage supplier qualification and on-going system review including supplier audit scheduling / performance and supplier corrective action.

• Perform gap analysis between approved validation criteria, standard operating procedures and master device records / master batch records.
• Redesign quality documentation systems such as batch records, device history records and standard operating procedures to compliance with applicable regulations and standards, approved validation criteria and client.
• Draft and implement quality documentation style guide to simplify and standardize batch record, device record and work instruction documentation

• Perform process flow mapping of manufacturing processes. Redesign batch records and device history records to improve the flow and accuracy of the document, reducing the number of documented entries, time to review.
• Identify and recommend production process improvements and efficiencies in tableting facilities (fluid bed granulation, blending, compression, coating, laser drilling, and imprinting operations), in-vitro diagnostic.
• Draft client Quality Manuals to comply with QSR and ISO13485.
• Analyze and improve workflow management and control within Quality Control laboratory. Establish and implement workflow standards and performance tracking. Design and implement controlled analytical worksheets to.

• Perform process flow mapping of manufacturing processes. Redesign batch records and device history records to improve the flow and accuracy of the document, reducing the number of documented entries, time to review.
• Install and validate 21 CFR part 11 compliant electronic document management system software.
• Train customers on the use of electronic document management system software.

• Monitor, measure, and report Supplier Performance.
• Purchase pharmaceutical ingredients & secondary packaging to support the manufacturing plan.
• Inventory planning and investment of specific commodities.
• Expedite and verify delivery schedules of incoming materials.
• Communicate with various internal customers on status of these deliveries.
• Manage the Supplier relationships and enhance competitive position with these suppliers.

Bs, Microbiology

Aa

High School Diploma