Dunellen, New Jersey, United States
Motivated and accomplished professional with over 20 years of experience in the pharmaceutical industry with extensive involvement in Equipment / Utilities Qualification, Cleaning Validation, Process Validation, Packaging Validation, Computer Validation, Process Engineering, Investigations, CAPAs, Change Requests, and Compliance Monitoring. Possess strong working knowledge of cGMP regulations and technical understanding of the solid dosage, oral liquid, cream /ointment, and parenteral pharmaceutical processes and engineering practices. Excel at fast paced environments with the ability to work on multiple projects with short deadlines. Over ten years experience supervising and managing personnel and contractors
• Manage major stake holders (Facilities and Engineering, MS&T, QA, QC, and IT) in driving the qualification and validation strategy for the Cell & Gene Therapies East Hanover site. • Train colleagues on the East Hanover team on various qualification and validation practices. • Manage Quality oversight to complex qualification activities and projects. • Provides timely review and approval of Equipment and Process Validation plans, protocols, summary reports and deviations. • Coordinates and develops with PU, MS&T, OPS, and QC qualification projects and plans and identifies the critical to quality parameters impacting qualification activities. • Reviews and approves Site Validation Master Plans, Risk and Impact Assessments as appropriate. • Provides QA review and guidance on asset and process change requests in consultation with change request owners to evaluate validation impact. • Advises and consults with other departments on equipment, analytical instruments and computer system validation. • Implement and maintain up to date the site validation compliance program and strategy. • Acts as QA Validation subject matter expert who liaises with QA during health authority inspections
Provide QA oversight for investigations, CAPAs, change requests, SOP’s, qualification / validation protocols and reports, complaints, batch record review and disposition, APRs, self-inspections, and health authority inspections. Drive activities associated with event resolution of manufacturing investigations, lab investigations, and CAPAs with focus on managing, organizing, and attending cross functional meetings to lead / facilitate proper completion of investigations. Provide support to various departments (i.e., Production, Packaging, IT, QC Analytical, QC Micro, Facilities / Engineering) in the investigation process and follow-up to assure timely deviation closure. Establish independent quality evaluation of investigation reports including root cause analysis, corrective action / preventive action identification, CAPA effectiveness checks, and trending. Responsible for overseeing batch record review, batch disposition process, and QA shop floor activities. Ensure safe release of products in accordance with site Quality procedures and requirements. Support health authority audits and global QA internal audits. Facilitate audit responses. Manage and conduct self-inspections of areas to ensure internal procedures and requirements are being followed. Manage change control process ensuring proper quality review of change requests, impact assessments, and verification of required documentation to close change controls. Write, review, and approve Quality Risk Assessments, Quality Plans, APRs, SOPs, and specifications as needed. Track and trend quality metrics associated with deviations, CAPAs, change controls, complaints, and batch disposition. Manage and present quality metrics in monthly Quality Review Board meetings.
Responsible for managing Commissioning, Qualification, and Validation of new Sterile Manufacturing facility. Scope of project included commissioning and qualification of: o Sterile vial filling line (i.e., vial washer, depyrogenation tunnel, filler, capper) with restricted access barrier system o Freeze Dryer with automatic loading and unloading system o Steam and Vaporized Hydrogen Peroxide Sterilization Systems o Clean Utility Systems (i.e., Purified Water, WFI, Pure Steam, Compressed Air, Nitrogen) o Labelling and Packaging Line o Building Environmental Monitoring System o Quality Control Laboratory Equipment Write, review, and approve URS, SCCR, FMEA, DQ, IQ, OQ, and PQ documents pertaining to new process equipment and clean utilities. Core team member during internal and FDA audits.
Responsible for managing Validation / Qualification staff that supported over 20 contract manufacturing clients for both Product Development and Commercial Operations. Write, review, and approve Validation documents pertaining to Qualification, Cleaning Validation, and Process Validation of solid dosage formulation, oral liquid, suppository, and sterile ointment products. Subject Matter Expert (SME) for Cleaning Validation. Developed Cleaning Validation Matrix at facility. Evaluated new API’s being introduced into the facility to determine Cleaning Validation impact. Determined residual cleaning limit values for API’s and cleaning detergents for development of Cleaning Validation Test Methods. Established clean hold time limits (micro and chemical) for solid dosage and oral liquids processing equipment. Managed and tracked Change Control (CR) process at facility from initial stage of CR being issued, through the review process, approval process, and completion / closeout. Also responsible for assessing Validation impact of CR’s. Core team member during customer and FDA GMP audits. Interacted with Quality Assurance in drafting responses to outside auditor / customer observations / comments. Write, review, and approved investigations and CAPAs related to Cleaning Validation, Process Validation, and Equipment / Utility Qualification events / failures. Write, review, and approve SOPs pertaining to Cleaning Validation, Equipment / Utilities Qualification, and Process Validation . Interact routinely with Quality Assurance, Product Development / Formulations, Operations, Analytical Development, and clients on products being introduced into the facility
Supervised Qualification Engineering Staff within Engineering Department. Wrote, reviewed, and approved Qualification documents pertaining to the following o Creams / Ointments and Suppository Manufacturing /Packaging Equipment - Comadis / IWKA Tube Fillers, Sarong Fillers, Cartoners, Checkweighers, Automated Batching Kettles, Tablet Fillers, Cappers, Induction Sealers, Blister Machines o Utilities (Compressed Air System and USP Purified Water System) o Packaging Line PQ’s (suppositories, creams, ointments, tablets) o Computer Systems (Maintenance Management Systems) Oversaw and maintained USP Water system at facility which included routine sanitization of system, coordinating changing of mixed, anion, cation, and carbon beds. Wrote all Change Controls related to Manufacturing, Packaging, and Utility upgrades. Wrote all Validation, Packaging, and Manufacturing SOPs pertaining to Equipment Qualification, Setup / Operation of Packaging and Manufacturing Equipment. Wrote and reviewed investigations and CAPA’s related to Packaging, Manufacturing, and Utility non-conformances. Monitored and tracked Qualification / Re-Qualification projects, investigations / non-conformances within the Engineering Department. Developed Packaging Qualification parameters for acceptable torque, induction seal, and speed settings on Packaging Lines. Interacted with Regulatory Compliance and Quality Assurance in drafting responses to outside auditor observations / comments. Interacted with auditors (i.e., FDA officials and customers) during GMP audits.
Supervised Qualification personnel and contractors in daily activities for New York, New Jersey, Virginia, and Ohio Manufacturing sites. Traveled regularly to VA, OH, NY, PA, and NJ sites to monitor, manage, and assist Qualification personnel in projects Wrote, reviewed, and approved Qualification / Re-Qualification protocols and reports, URS Documents, Risk Assessment Documents, Validation Project Plans, and Commissioning Documents Reviewed and approved Change Controls and created/updated Validation SOPs and Guidance documents that pertained to Qualification of Equipment, Facilities, and Environmental Conditions and Classes. Monitored and tracked training history of Qualification Engineers and technicians at all US sites. Monitored and tracked Qualification / Re-Qualification projects, investigations / non-conformances for each of the US sites. Interacted with Regulatory Compliance and Quality Assurance in drafting responses to outside auditor observations / comments. Interacted with auditors (i.e., FDA officials) during routine GMP audits, pre-approval inspections. Interacted with European Sites (Croatia and Poland) in developing Global Standard Qualification policies. Maintained Equipment Qualification database that stores qualified parameters and qualification history of manufacturing equipment at all US sites.