Quality Assurance

Name: Gutenberg D Ahimon

Contact: 201-***-****

Email:*******@*****.***

Current Loc: North & Central NJ

PROFESSIONAL SUMMARY

Over seven years of experience as Analytical Chemist in highly regulated Pharma environments (QC/QA Laboratory, R&D SOPs, cGMPs, ICH Guidances, FDA Guidances and official compendial standards such as USP/NF, EP, AOAC and FCC.

Hands-on responsibilities for GMP/GLP testing of samples for release testing and stability testing including measurement of physical properties, assay, impurities, dissolution, and identification using HPLC, UPLC, UV-Vis, IR, and classic techniques for small molecules, peptides, and proteins .

Over Five years of experience Computer Systems Validation and Good knowledge of LIMS.

Thorough understanding of HP Quality Center and Quick Test Pro software.

Experienced in developing Installation, Operational and Performance Qualification (IQ, OQ and PQ) Validation Protocols and reviewing, writing Standard Operating Procedures (SOP)

Excellent understanding of the Software Development Lifecycle (SDLC) and QA Methodologies

Expert knowledge of FDA 21 CFR Part 11: Electronic records and Electronic Signatures.

A good understanding of GMP, GCP and GLP as related to the FDA regulations.

Experienced in Sample preparation and Analysis following official methods and company/laboratory SOPs, including wet chemistry, extractions, quantitative measurements and instrumental analysis with a strong background using GC-MS, GC-FID and HPLC.

Proficient in Calibration and Validation of Laboratory Instruments: Dissolution Apparatus, Fermenters, Reactors, UV Spectrophotometers, GC, and HPLC's.

Environment/Technical Skills

Computer System Validation: 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 5 & 4, VMP, Validation Protocols (IQ, OQ, PQ), SOPs, RTM, LIMS, AERS, VSR, Audit Trials .C, PL/SQL, PASCAL .MS DOS, MS Windows 95,98, NT/2000, XP, UNIX . Oracle 10g, f10i, MS Access, Chromatography Data Systems (CDS) Win Runner, QTP, Load Runner, Test Director, Quality Center, Rational Robot Scanning Electron Microscope (SEM), High Performance Liquid Chromatography (HPLC), Nuclear Magnetic Resonance (NMR), Mass Spectroscopy (MS), Gas Chromatography (GC), Autoclaves, Plate Readers Lyophilizers, ERP MS Office (Word, Excel, PowerPoint, Visio, Project),.

Project Summary

Plenum Scientific Research, Hackensack, NJ June 2012 - Present

QC/QA Chemist

Plenum Scientific Research is one of the leading chemicals manufacturer and scientific research & development Laboratory in established since early 1990s in New Jersey. Plenum S.R is customer-centric and research-driven company that uses the innovative and creative minds of its personnel to respond to the toughs R&D challenges from pharmaceutical and biotechnology clients. In this position, my role was to conduct tests related to the development product, intermediates, and finished products in compliance with GLP/GMP regulations.

Responsibilities:

Developed Analytical Methods of new DS and API by using HPLC, GC, UV-VIS, IR, and wet chemistry instruments.

Performed analyses of raw materials, stability of in-process samples, bulk, intermediate, and finished products.

Prepared reagents, solutions, and standards. Maintained instruments, and apparatus according to established procedures to support testing activities of the unit.

Monitored and verified quality in accordance with statistical process or other control procedures.

Determined conformance to accepted specifications for a particular chemical or physical property.

Ensured compliance of cGMP/GLP in the QC laboratory.

Assisting with the maintenance, reviewing, reporting and verification of instruments and documents.

Johnson & Johnson, Raritan NJ Feb 2012 - June 2012

Validation Analyst I

Johnson & Johnson is among the world leading health care company. In recent years, J&J launched a number of innovative new products to address unmet health care needs across the globe, and advanced their pipelines, which today are among the best in the industry. J&J strengthens their product portfolios and leadership positions in many areas, including immunology, oncology, and surgical devices and emerging markets. J&J is delivering meaningful innovations in health care and building a more agile company to seize market opportunities. The Project (Global Empower) aimed to implement Waters’ Empower 3 Chromatography Data System to all sites where Empower CDS is used.

Responsibilities:

Developed URS and FRS documents Excel Spreadsheets Maintained in Quality Center 10.0

Created, maintained, and reviewed IQ, OQ, and UAT/PQ Test Scripts in Quality Center

Created and maintained document status and results of all testing activities using HP Quality center 10.0 and Doscpace.

Developed validation Documents, IQ, OQ, and UAT/PQ protocols, and validation summary reports, Validated.

Developed OQ test scripts for Empower 3.

Dry Run IQ/OQ/UAT Tests using Empower 3 CD Software and reviewed Test cases.

Developed and reviewed IQ, OQ UAT System Test Reports Documents.

Developed and update according to Compliance Plan validation deliverable such Functional Custom Exist Checklist, Technical Custom Exist Checklist, Verify and Deploy Exist Checklist, and Custom Compliance Report.

Worked on the Requirement Traceability Matrix and updated it regularly.

Performing gap analyses and risk assessments (GMP, GLP, GCP, 21 CFR Part 11)

Peer-reviewed executed Test Results in Quality Center and submitted for Approval.

Environment/ Technical Skills

21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 5, Validation Protocols (IQ, OQ, PQ), Quality center 10.0, SOPs, RTM, LIMS, AERS, VSR, Audit Trials. MS DOS, MS Windows 95, 98, NT/2000, XP, UNIX. Oracle 10g, f10i, MS Access.

CISPharmaceuticals. Inc., Cranbury, NJ Feb 2011- Jan 2012

Validation Engineer II

CisPharmaceuticals, INC, with principal offices in Cranbury, NJ, is a U.S.-based firm that

develops, manufactures and distributes generic pharmaceuticals regulated and approved by the

U.S. FDA. Known as “Generic’s New Generation,” the company utilizes its newly expanded R&D

and manufacturing capabilities to conceive breakthrough developments with lasting impact for a

robust product pipeline. Efficient ANDA approvals and diverse product acquisitions are key to

CisPharma’s aggressive growth strategy, as is the company’s strong commitment to deep customer

relationships and maximum value creation. CisPharma delivers high-quality products, superior service

levels and dynamic value throughout the pharmaceutical industry. This project aimed to assure compliance for all Lab and manufacturing equipment.

Responsibilities:

Involved in writing the validation deliverables for Lab instruments: HPLC, FTIR, and UV.

Developed and reviewed URS, FRS and design documents for reactors and fermenters.

Created and maintained document status and results of all testing, coordinated data collection and data migration using HP Quality center 9.2.

Executed and planned tests in the HP Test Center tool and document the tests, analyze the test results to determine repairs priorities.

Developed and reviewed Test protocols and developed and executed test cases accordingly.

Worked on the Requirement Traceability Matrix and updated it regularly.

Performing gap analyses and risk assessments (GMP, GLP, GCP, 21 CFR Part 11)

Developing and maintaining GAMP4 lifecycle documentation, including user requirement specifications, functional specifications, risk assessments, and traceability matrices for CDS,

Designing and validating custom applications of Chromatography data system, databases (Oracle 11g, Microsoft SQL) and spreadsheets(excel, word) using Edit Grid and Lotus .

Upgrading, configuring and validating networked chromatography equipment (HPLC, GC, and CE), such as Agilent’s ChemStation / ChemStore and Waters’ Empower.

Completed 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems, including remediation and validation of deficient systems.

Directed validation of trace level analytical methodology, preparation of SOPs, assignment of limits, and presentation of results.

Completed IQ, OQ, and PQ of manufacturing equipment, such as tablet presses, sterile filling lines, mixing equipment, packaging lines, autoclaves, incubators, labeling and barcoding systems, and organic synthesis equipment.

Environment/ Technical Skills

Computer System Validation: 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 4, VMP, Validation Protocols (IQ, OQ, PQ), Quality center 9.2, SOPs, RTM, LIMS, AERS, VSR, Audit Trials. MS DOS, MS Windows 95, 98, NT/2000, XP, UNIX. Oracle 10g, f10i, MS Access.

CISPharmaceuticals. Inc., Cranbury, NJ March 2010 - January 2011

Quality Assurance Specialist

CisPharmaceuticals, INC, with principal offices in Cranbury, NJ, is a U.S.-based firm that

develops, manufactures and distributes generic pharmaceuticals regulated and approved by the

U.S. FDA. Known as “Generic’s New Generation,” the company utilizes its newly expanded R&D

and manufacturing capabilities to conceive breakthrough developments with lasting impact for a

robust product pipeline. Efficient ANDA approvals and diverse product acquisitions are key to

CisPharma’s aggressive growth strategy, as is the company’s strong commitment to deep customer

relationships and maximum value creation. CisPharma delivers high-quality products, superior service

levels and dynamic value throughout the pharmaceutical industry.

Responsibilities

Carried out processing steps in a batch manufacturing environment.

Calibrated and Maintained manufacturing equipment such V blenders, sterile rotary piston pumps filling lines, saturated steam autoclaves, vial filling lines, lyophilizers.

Weighed, measured and checked raw material to assure batches manufactured contain proper ingredients and quantities.

Supported pharmaceutical dosages forms and API analytical testing in a GMP environment, performed routine stability testing.

Coordinated quantitative and qualitative analytical testing of developmental, clinical, and commercial pharmaceutical and related products (including raw materials, in-process materials, and finished products) and reporting of results.

Computerized test systems, manufacturing facilities, process utilities, and manufacturing equipment (cappers).

Maintained records and work area to comply with SOP’s, company policies and in accordance with GXP.

Developed and performed UAT for CDS equipment:(HPLC and GC)

Audited Chemicals suppliers and presented findings.

Audited laboratory operations and brought laboratories into compliance with GLP.

Developed and validated analytical testing methods and prepared related SOPs.

Reviewed GCFID, GCMS, HPLC, and related test results against established procedures and policies.

Wrote System Configuration Specification and Validation summary report for lab equipment: HPLC, GC… etc.

Environment

Computer System Validation: 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 4, VMP, Validation Protocols (IQ, OQ, PQ), SOPs, RTM, LIMS, AERS, VSR, Audit Trials Win Runner, QTP, Load Runner, Quality Center, Rational Robot .Scanning Electron Microscope (SEM), High Performance Liquid Chromatography (HPLC), Nuclear Magnetic Resonance (NMR), Mass Spectroscopy (MS), Gas Chromatography (GC), Autoclaves, Plate Readers.

TIME CAP LABS, INC. Farmingdale, NY February 2009 – December 2009

Lab Chemist /Associate Validation Engineer (II)

Time-Caps Labs, Inc. is a full-service pharmaceutical company that develops, manufactures, markets and distributes difficult to develop, technology-driven specialty generics for the US and European markets. With its core competencies in generics, Time-caps Labs has also filed for multiple new products with the FDA and is anxiously awaiting approval. The project envisioned to apply a validation process to assure regulatory compliance for production equipment and to maintain products in compliance.

Responsibilities

Responsible for writing and reviewing Validation protocols, final reports, deviations, and SOP’s for Agilent ChemStation.

Maintained records and work area to comply with SOP’s, company policies and in accordance with GMP/ISO 9000 standards.

Supported pharmaceutical dosages forms and API analytical testing in a GMP environment. Perform routine stability testing. Perform testing related to method development, validation and method transfer.

Developed and executed IQ, OQ, PQ, and SOP’s for Autoclave, Incubator Shakers.

Collaborate with Quality and manufacturing in the activities required for Validation completion within a very tight budget and schedule.

Performs manufacturing and/or assembly of chromatographic media and/or components.

Operated production equipment.

Reviewed and approved validation documentation including Requirements Specifications, System Design Documents, and Test Strategy document, System Test Scripts, User Acceptance Test Scripts, executed Test Scripts and Traceability Matrix.

Provided guidance and strategies to team members to improve efficiency and quality.

Environment

Computer System Validation: 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 4, VMP, Validation Protocols (IQ, OQ, PQ), SOPs, RTM, LIMS.

MEDRAD, INC Healman center, Pittsburg (PA) Sept 2008 – December 2008

Regulatory Associate (II)

MEDRAD, Inc. develops, markets and services medical devices used to diagnose and treat disease. Its product offerings include fluid injection systems for radiology and cardiology, endovascular devices for the safe treatment of cardiovascular disease, magnetic resonance-compatible accessories and equipment services. The project involved validation of automated computers system used in production and R&D activities.

Responsibilities

Developed User/Functional Requirements, IQ/OQ/PQ Test Scripts and a Traceability Matrix.

Developed Validation Plan, Validation Protocol, IQ/OQ/PQ Test Scripts, Traceability Matrix, System Overview and Validation Report for Lab Instruments.

Developed all validation deliverables for spectrophotometer systems, environmental monitoring system, flow cytometry systems, SAS macro, slide strainers and clinical chemistry systems.

Developed testing strategy, change control process, test scripts, schedule and worked with vendor to address bugs for the System upgrade.

Developed Test cases for the spectrometer as well as for the related softwares.

Involved in document management and project management through Documentum eRoom.

Wrote documentation for all aspects of the computer systems validation lifecycle in accordance with CFR 21 Part 11 including IQ, OQ, PQ.

Made deviation investigations, SOP and quality system development and equipment qualification.

Validated Audit Trail functionality.

Completed periodic review reports.

Assisted with development of validation and system SOPs.

Developed spreadsheet to track periodic reviews for GLP systems in department.

Peer reviewed validation documents for others.

Environment

Computer System Validation: 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 4, VMP, Validation Protocols (IQ, OQ, PQ), SOPs, RTM, LIMS, Documentum, ERP MS Office (Word, Excel, PowerPoint, Access, Visio, Project).

CIPHARM, ABIDJAN, COTE D, IVOIRE June 2007 – September 2007

QC Associate (II)/Regulatory Associate (II)

Founded in December 1986 and launched in May 1988, Cipharm is a limited company with a board of directors with a private-owned investment capital. Recognized as the global benchmark for quality and integrity. Cipharm is the Western African leader in manufacturing drugs in internationally standard condition environment: quality, safety and productivity and reduce risk. Cipharm’s original goal which was to build a major industrial site and give the Cote D Ivoire first laboratory in full compliance with international standards has been achieve since then and:

Improving health is at the heart of issues critical economic and human development in Africa. This project was an enhancement project to implement, develop and maintain compliance status of computer system and production equipment as required by regulation agencies.

Responsibilities

Worked with cross-functional technical teams to deliver projects from a variety of technical backgrounds

Conducted testing of the performance of raw materials utilizing methods and instrumentation in the Materials Science department.

Reviewed and approved GCFID, GCMS, HPLC, and related test results against established procedures and policies.

Participated in the development and improvement of the manufacturing processes for existing and new products.

Conducted audits to determine the Validation status of systems in various departments.

Involved in full Validation Development Life Cycle and maintained Project Schedules.

Conducted Performance testing by using Performance Qualification.

Ensured that the system is in compliance with the 21 CFR part 11 electronic records and electronics signatures regulatory standards which included automatic date-time entry, multi-level password security and secure system sign-on features.

VALDAFRIK, Senegal (West Africa) June 2004 – August 2006

QC Laboratory Chemist II /Associate Validation Specialist (II)

Leader in West Africa, Plant Production Africasoins Valdafrik, Laboratoire Canonne is established in Dakar since 1943. Today it is one of the largest sites of drug production in West Africa. Its produces large panel of health and care products known for their quality and affordable prices. Valdafrik’s line of product is made of for areas: insecticides, candy, pharmaceutical and Arabic gum with very well-known trade names like YOTOX, VALDA, SALVATIS.. The plant meets the requirements of local authorities and international quality standards. The Project aimed to ensure international compliance for drug products.

Responsibilities

Reviewed, and validated analytical methods, company and laboratory SOPs, and other operating, safety, and quality documents.

Assist in post-project Quality Assurance (QA) and knowledge management

Involved in receiving and recording incoming samples, cutting, milling, and weighing samples.

Developed, submitted, and filed reports on client sample tests, correlation tests, calibration, validation, proposal, and other projects.

Worked on Routine operation, maintenance, calibration, qualification, and trouble-shooting of laboratory equipment and instruments.

Maintained laboratory instrumentation, logbooks, test results, databases and notebooks in compliance with laboratory SOPs and cGMPs as they relate to the QC Laboratory (i.e., 21 CFR 211.65).

Responsible for all version and change control as they relate to all lab documentation.

Environment

Dissolution Apparatus, Spectrophotometers, IR, GC/ HPLC, cGXP (cGMP, GCP, GLP, GDP), GAMP 4, VMP, Validation Protocols (IQ, OQ, PQ), SOPs, RTM, LIMS, AERS, VSR, Audit Trials

Microsoft Office, including Word, Excel, PowerPoint

Education

• Masters in Pharmaceutical Engineering (NJIT)

• Certified Chemical Technician (AIPT, Hackensack NJ).

• BS Biomedical Engineering NJIT (May 2008 – NJIT).

• BS Pharmaceutical Engineering (University of Ivory Coast JUNE 2000)

Contact this candidate