Industry Consultant

SUMMARY

  • Broad Range of experience in Quality Assurance, Validation, and Technical Services.
  • Deep understanding of GCP, GMP and GLP in both research and manufacturing of oral solid dose, semi-solids, liquids, suspensions, parenterals, vaccines, medical devices, and biotechnology.
  • Technical expertise in cleaning validations, process and packaging validations, equipment/facilities/utilities qualifications, and SIP/CIP.
  • Expertise in non-conformances, manufacturing investigations, complaint investigations, CAPA, root cause analysis, and change control, auditing, vendor qualifications, supplier quality agreements, and raw material qualifications.
  • Developed quality manuals, quality policies and procedures, conducted audits for PAI inspections, performed gap analyses, developed, wrote and presented training programs, and authored technical documents.
  • Extensive experience in pharmaceutical/medical device/Biotech manufacturing processes including aseptic and sterile environments.
  • Project management and consulting/auditing expertise in Quality Assurance and Validation.
  • Data Integrity, SDLC, and computer system validation requirements experience.

EDUCATION

Master of Science, Quality Assurance and Regulatory Affairs

Bachelor of Science, Biology

 

PROFESSIONAL EXPERIENCE

Azzur Group, LLC.

Sr. Consultant Current

  • Azzur Group is a premier professional service provider for the Health and Life Sciences industry. Key services include Engineering, Regulatory Consultation & Remediation, Project Management, Business Strategy, and Technical Services. Recent projects include data integrity assessments for computerized systems, authoring SOPs, master plans, and work instructions. Also, participated in the implementation of an electronic validation document management system.

 

Vali-Tech Services, Inc.

Owner/Principal Compliance/Validation Consultant 12-01 - Present

  • FDA warning letter remediation for manufacturing investigations.
  • Working as the Associate Director, GMP QA including review and approval of CAPA, investigations, OOS investigations, generation of quality SOPs, review and release of API and clinical study products, review and approval of analytical method validation protocols/reports.
  • Filler development and validation for large vaccine manufacturer, IOPQ remediation for piping, equipment, CIP skids, and other manufacturing equipment for large Global OTC company, CAPA and non-conformance investigations for large biotech company, and GMP evaluation and compliance auditing.
  • Extensive equipment qualifications including temperature mapping and qualification of cold and hot boxes for Global consumer healthcare company, Quality Assurance. consulting and auditing of recently redesigned validation programs for Global consumer healthcare company under consent decree, project management, development of equipment commissioning and packaging validations, writing and developing Quality, Regulatory and Compliance Policies and Procedures, training, Quality Assurance auditing of new manufacturing facility for PAI readiness, audit of SOPs and IOQ documents, review of batch records and gap analyses. Advanced in 21 CFR Part 211, Part 11, 820, 803, and ISO13485 and ISO9001.

 

Noramco, Inc. Wilmington, DE

Sr. QA Specialist 10-18 - 09-19

  • Review/approve events/investigations, CAPAs, OOS investigations, write/review/approve SOPs, review/release of manufacturing/processing batch records for API product, SME and reviewer/approver of equipment IOPQ protocols/reports, review/approval of cleaning/process validation protocols/reports including sampling plans/statistical data, review/approve master batch logs, review/approval of change controls, host customer audits, and perform internal audits. Back room support for FDA inspections, QA Lead for the design and implementation of the chemical hose project and QA representative for NPI and tech transfers. Present project charters to the Senior Management Team. Provide data for continuous improvement projects and quality standards.

Sr. Process Engineer 04-18 - 10-18

  • Responsible for the API manufacturing processes and intermediates. Provides technical support for processes including performing analysis to measure process performance and implementing improvements in process cycle time, yield, and quality to maximize operations efficiency. Support introduction and validation of new and existing products.
  • Provides expertise to new equipment design, installation and qualification.
  • Plans and conducts activities related to the development of new processes including researching current and emerging technologies, evaluating process cost, quality and capability alternatives, and performing process characterization and optimization using designed experiments, and problem solving and decision-making tools.

 

Wyeth-Ayerst Laboratories West Chester, PA

Senior Technical Expert 04-01 - 11-01

  • Responsible for receiving and implementing management directives and determining regulatory/logistical impact on plant operations.
  • Develop, schedule, execute and provide documentation for formal training of Tech Service staff. Conduct internal audits of the Tech Service operation to find and correct problems with work methods, processes, documentation, etc. Actively represent Tech Services in successful product transfer and new product launch. Lead the process validation effort for new products including equipment IQ/OQ/PQ.
  • Schedule launch dates, prepare and execute protocols, resolve problems, validate and prepare defense of regulatory submissions.
  • Prepare Technical Reports to document technical activities in support of regulatory compliance and submissions.
  • Prepare reports for product specifications, NDA filings and annual NDA updates to maintain proper control of production and to ensure compliance with regulations.
  • Review equipment specifications against the proposed application and cGMPs.
  • Assure re-qualification schedule is met. Act as technical resource to Tech Service staff. Oversee completion of tasks identified in the Master Validation Plan.

 

Teva Pharmaceuticals, USA Sellersville, PA

Associate Quality Assurance Manager 01-01 - 04-01

  • Plan, organize and direct the activities of the QA office Release/Analysis Group. Assure compliance with regulatory and corporate requirements through document review of Batch Records, laboratory reports, investigations, complaints and annual product reviews.
  • Coordinate and conduct investigations when necessary. Review and approve MIR and MDR investigations. Assure that the QA staff is conducting timely review/completion of Batch Records and investigations.
  • Assure follow-up is tracked and completed in a timely manner. Assure that QA systems and procedures are maintained and are current.
  • Write or assign personnel to write necessary SOPs.
  • Approve relevant departmental SOPs. Review technical reports (protocols, validation, qualifications).
  • Participate or direct personnel in the performance of Audits (internal/external). Assure that all training for QA Staff is performed and documented.
  • Work with Planning and other departments to assure that production and validation schedules are met.

 

Colorcon West Point, PA

Area Technical Manager 01-00 - 12-00

  • Provide technical assistance to end-users before and after the sale of all Colorcon pharmaceutical products.
  • Ensure proper and efficient use of Colorcon’s products by participating in technical application discussions with end users and representatives on the phone. Participate in technical application and troubleshooting of all Colorcon’s products in the Coating Laboratory.
  • Conduct analysis and evaluation of existing formulae for maximum product performance. Provide consultation to customers regarding color selection and regulatory requirements. Perform technical assistance and consultation at end user locations to ensure efficient and optimal use of Colorcon’s products.
  • Troubleshoot customer facility and equipment as they relate to Colorcon’s products end use performance.
  • Presentation of technical information for both internal and external seminars and schools.

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Johnson & Johnson Fort Washington, PA

Research Associate 11-96 - 12-99

  • Provide technical support to manufacturing operations.
  • Design and execution of laboratory, plant scale and validation batches. Direct activities of production operators during manufacturing of plant scale and validation batches.
  • Prepare development and validation reports and protocols including equipment IQ/OQ/PQ and process validations.
  • Preparation and review of experimental manufacturing requisitions and stability batch records to ensure compliance with all department SOPs and GMPs.
  • W rite, review and approve Master Formula Records for formulation/processing changes made to existing products.
  • Evaluate alternative formulation and processing options. Audit of outside vendors as required.
  • Evaluation of alternative raw materials for use in existing products. Review and approval of manufacturing requisitions. Review and approval of Non-Conformance Reports for Liquid products.

 

Warner-Lambert Company Lititz, PA

Process Scientist 01-96 - 11-96

  • Design and execute pilot scale-up procedures for new and existing products to establish and/or improve manufacturing processes. Provide technical support to manufacturing operations.
  • Review and approve validation reports and protocols for technical and scientific accuracy and logic.
  • Analyze data and recommend procedures to troubleshoot manufacturing operations.
  • Evaluate and recommend equipment and raw materials to optimize process efficiency and quality.
  • Provide technical support and coordinate activity of R&D, Quality Assurance, Manufacturing and Engineering to transfer new formulae and processes to the plant. Prepare all necessary batch and process documentation. Write and present technical reports documenting the technology transfer, scale-up, troubleshooting and equipment/raw material evaluation activities.
  • Evaluate all formulae and processes and take necessary action to guarantee adherence to regulatory, quality and compendial standards. Investigate and implement methods to reduce production costs while maintaining consistent quality. Evaluate new equipment and make recommendations that will increase production efficiency, reduce total cost or increase product quality. Evaluate and identify alternate raw material suppliers.

 

Validation Specialist 05-94 - 01-96

  • Develop and perform process (new and reformulated), product, packaging and cleaning validations, as well as facility qualifications including protocol development, monitoring production batches, statistical analysis, reports and summaries for new and existing products.
  • Design and perform equipment installation and operational qualifications. Investigate process and equipment changes and recommend the necessary re-validation or re- qualification studies.
  • Review and evaluate Production Batch Records and recommend changes based on Validation study results. Review and evaluate plant operating procedures and recommend procedure changes based on validation/qualification study results.
  • Serve on assigned project committees to review validation and qualification studies.
  • Direct activities of Production personnel, validation technicians or other personnel integral to validation and qualification studies.
  • Monitor stability program results from validation studies and summarize the data in reports along with conclusions and recommendations. Review change control documentation and recommend and execute the identified re-validation activities. Supervise activities/projects conducted by contractors.

 

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