Quality Control Management

Ihab Guirguis

** *. ********* ****** ******, NJ *8831

Home: 732-***-**** Cell: 609-***-****

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PROFILE

** ***** ** ********** ********** in the Pharmaceutical, Medical device, (Drug-coated Stent) and Biomedicine industries with cross-functional in Quality Assurance, Quality Control analytical chemistry laboratory. Demonstrate success in managing product release, LIMS, stability programs, analytical chemistry laboratory to improve efficiency. Expert technical knowledge of GMP, FDA (21CFR Parts11, 210, 211, 21CFR Parts 600, 610, 680 and 21CFR Part 820), USP and ICH regulatory policies and procedures. Quality on the floor. QA oversight of aseptic processing.

TECHNICAL SUMMARY

Manage all activities of the quality control department and analytical chemistry laboratory staff.

Quality on the floor QA oversight of aseptic processing.

Method Validation/Method Transfer.

GC, HPLC, UPLC, UV / VIS, FTIR, automated dissolution systems, Potentiometer Titration, KF Titration.

ChemStation,Cerity, Millennium32, Empower 1154 and Empower 3 - data acquisition systems.

Stability program management (stability protocol, study initiation, results analysis).

Manage Laboratory Information Management Systems (LIMS).

Process Excellence - Six Sigma “Green Belt”.

Train the Trainer corporate learning & operations training.

PROFESSIONAL EXPERIENCE

CYALUME TECHNOLOGIES, Bound Brook, NJ Current

Quality Control Manager

Manage laboratory resources to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers. Ensure all laboratory activities are conducted in accordance with government regulations, safety requirements, and Company policies. Provide process improvements, laboratory regulatory compliance, technological innovation, and development of laboratory procedures in accordance with current testing guidelines and current Good Manufacturing Practices (cGMPs).

Ensure the appropriate oversight and guidance for laboratory investigations including reviewing investigations to ensure that reports are consistent, complete and in alignment with applicable standards and procedures with appropriate content and references.

Ensure that all laboratory personnel have the required education and training to perform assigned job responsibilities.

Provide oversight of Quality Agreements with Contract Laboratories to ensure excellent and appropriate communication between laboratories.

Review and approve technical protocols and reports to support validation/verification and qualification activities.

Monitor laboratory metric trends on a regular basis and ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists.

Assess new technology and laboratory automation in collaboration with Regional Laboratory Leaders to increase laboratory efficiency, reduce testing time, reduce data variability, minimize chemical consumption and reduce waste.

Ihab Guirguis

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INTEGRA LIFESCIENCES, Plainsboro, NJ 2013-2015

Analytical Laboratory Supervisor

Supervised all activities of the quality control analytical chemistry laboratory staff .

Established priorities and work schedules with other team leaders. Evaluated the performance of assigned personnel according to company policy. Assured the laboratory operates in a compliant manner consistent with cGMP’s and other internal standards. Reviewed and approved laboratory data generated by analytical chemistry laboratory staff for completeness and accuracy.

Demonstrated leadership including performance reviews to accomplish lab personnel development and organizational goals.

Managed lab personnel weekly schedule and work assignments to ensure efficiency and cost effectiveness.

Supported test method validation and transfer to achieve new product development (NPD) and site validation.

Represented department as technical liaison with plant management to improve cross-departmental teamwork.

Managed the change control process to ensure SOPs revision compliance with applicable regulations and policies.

Maintained GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.

Supported in preparing and participating in FDA, European Medicines Agency (EMA), customer audits, BSI recertification.

Managed Out of Specification (OOS) investigations, Non-conformances, and Corrective Action/ Preventative Actions (CAPAs).

Monitored and reported trending reports for In-process, Finished Goods and stability testing results to prevent potential problems associated with either routine process batches or validation processes.

DENDREON CORPORATION, Morris Plains, NJ 2010-2013

Senior Quality Assurance Associate I

Performed batch record preparation, issuance and batch record review. Ensured GMP compliance for the disposition of raw materials and components. Track and trend deviations, non-conformances, corrective actions, OOS, change controls and investigations in support of management review. Conducted quality on the floor real time review and investigations, auditing and timely decisions. QA oversight of aseptic processing.

Supported commercial launch by completion QA training, proficiencies and trained other team member.

Represented department in cross-functional teams, projects and GXP-related problem resolution.

Provided support in investigations associated with product failures, product complaints and BPDRs.

Managed the change control process to ensure accurate, timely review, release the implementation of Standard Operating Procedures.

Performed quality on the floor to ensure full GMP compliance through aseptic cell processing in all departments.

Utilized LIMS and Oracle to review, approve and release raw materials and components.

CORDIS, a Johnson & Johnson Company, Warren, NJ 2005-2010

Senior Scientist

Performed Drug Eluting Stent analytical analyses. Maintained and resolved problems with laboratory equipment including GC with Headspace, HPLC, UPLC, FTIR, automated dissolution systems and wet chemistry. Developed and updated Standard Operating Procedures.

Implemented LIMS (LabWare LIMS Solution), conducted required validation studies and trained laboratory staff resulting in smooth transition.

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Developed and reviewed User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS), test plans, test cases, test scripts, test reports, test requirements, User Acceptance Testing (UAT) and IQ plans relating to LIMS software.

Trained laboratory staff on the transition from Millennium32 to Empower 1154 data acquisition system for system upgrade and increased functionality.

Generated significant savings through the transfer of Out of USA products from Latina and transfer of release testing from San German.

Tested market stability and clinical trial studies timely and accurately in compliance with applicable policies and regulations including FDA, USP, and ICH.

Initiated and reviewed laboratory investigations for out of specification and out of trend test results.

Ensured passing ISO audit and FDA inspection by preparing and responding to requests for information in a timely manner.

JOHNSON & JOHNSON, Consumer Companies, Inc., North Brunswick, NJ 1999-2005

Senior Scientist

Performed analytical analysis of raw materials, finished products for cosmetic, OTC, and medical device consumer products. Managed stability protocol, study initiation, analytical testing and stability results analysis. Supervised raw material laboratory to test and release in compliance with applicable regulations and policies including FDA, USP, ICH guidelines.

Managed the LIMS (Laboratory Information Management System) and trained laboratory staff to improve laboratory efficiency.

Conducted database maintenance and supervised user accounts in LIMS.

Outlined new reports and functionality in LIMS.

Monitored quarterly productivity of analysts and overall release time to identify areas for improvement.

Conducted statistical analysis of laboratory data and prepared reports to improve processes.

Performed out of specification and out of trend investigations OOS/OOT.

Coordinated calibration utilizing BlueMountain software.

Managed laboratory CAPAs (Corrective and Preventive Action) to ensure compliance and increase functionality.

Optimized and validated chromatographic parameters for new analytical methods.

EDUCATION

BS in Chemistry, Alexandria university, Egypt.

PROFESSIONAL DEVELOPMENT

Oracle ERP

Pilgrim Software Quality Management Software risk, compliance and quality management.

EDMS Electronic Document Management System.

Aseptic processing Aseptic Gowning Qualifications.

LabWare LIMS Solution

Waters Educational Services

ACQUITY Ultra Performance LC (UPLC) separation system

Millennium32 to Empower 1154 Upgrade Training

Millennium32 Training.

Johnson & Johnson

Process Excellence - Six Sigma “Green Belt” certification

MINITAB

Elements of Pharmaceutical GMPs

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