Validation Consultant

PROFILE

Mr. Lynch has more than fifteen years experience providing professional consulting services to the biotechnology, medical device, solid dosage and parenteral pharmaceutical industries with emphases in quality assurance and validation systems. His background includes project management, business development, batch record review for product release, CAPA/Deviation investigations, technical writing for quality documentation i.e.; IQ, OQ , PQ, Reports as well as field execution for various clients. His greatest achievement was given the opportunity to manage and mentor a third party documentation compliance team on behalf of a FDA Consent Decree at the Warner Chilcott /Pfizer / Warner Lambert Inc. site in Puerto Rico. His technical background includes strong emphasis in data evaluation, manufacturing equipment, facility, utility and cleaning qualifications. Mr. Lynch is a self-starter with proven leadership, interpersonal and communicative skills with multiple clients within the pharmaceutical industry. He has working knowledge of the following software applications: Trackwise, MIDAS, XpertVal (Merck System) Microsoft Windows XP (R) 4.0, Microsoft Project, Power Point and Microsoft Office (Word, Excel).

PROFESSIONAL SUMMARY

VALSOURCE LLC, DOWNINGTOWN, PA

VALIDATION CONSULTANT March, 2008 - Present

Mr. Lynch’s most recent assignments for ValSource LLC has been with Merck, West Point, Pa, Merck, Elkton, Va., MannKind Pharmaceutical, Danbury, Ct and Centocor Clinical Research facility in Radnor, Pa. His experience while working on these project sites included the following tasks;

Generate Validation IQ, OQ, PQ and Summary Reports for new Getinge Sterilizer

Execute Validation IQ, OQ, PQ for new Getinge Sterilizer and HVAC Systems

Developed and executed commissioning SATs for Getinge Equipment Washers and Sterilizer

Participated in Cleaning Verification Studies and SIP Studies

GMP and Quality Review of Protocols and Reports

DAY & ZIMMERMANN VALIDATION SERVICES, INC. GUAYNABO PR

PROJECT MANAGER June 1992-February, 2008

As Batch Certification Project Manager / Coordinator for the Dilantin 100 Mg Batch Certification Team, at the Warner Chilcott /Pfizer/Warner Lambert Inc., located in Fajardo, PR. Mr. Lynch’s duties included, but not limited to the coordination, auditing and release of all documentation related to manufacturing, packaging, quality control, raw materials and final product release for an FDA Consent Decree. He’s interfaced with the client on key CAPA investigations and issues, maintained the project budget and track product release activities, evaluated staff for annual appraisals, set individual goals and priorities for staff, thus far ensured that the scope of the project was consistently met on a daily basis. Additionally he also managed additional Day & Zimmermann personnel on and off site who were conducting various equipment and computer validation projects.

As Senior Validation Specialist consultant, Mr. Lynch was responsible for the development and execution of Installation/Operational Qualification (IOQ) protocols and summary reports for supporting equipment used for the Soft Gelatin Encapsulation and Hard Gelatin Encapsulation Operations at Baker Norton Pharmaceuticals, Inc., located in Miami, Florida

As Senior Validation Specialist consultant on two occasions, Mr. Lynch participated in the re-reevaluation and revision of reports, Standard Operating Procedures (SOPs) and IOQs for

autoclaves, vial/syringe tunnels and sterilization runs for Amgen’s Manufacturing Parenteral Formulation and Filling facility located in Juncos, Puerto Rico.

Page 2

As Validation Project Leader consultant, Mr. Lynch participated in a project to qualify the utility systems, equipment and critical manufacturing processes for St. Jude Medical, a manufacturer of heart valve devices, located in Aguas Buenas, Puerto Rico.

As Validation Specialist 1 consultant, Mr. Lynch was responsible for the development of SOPs and execution of cleaning, process and laboratory equipment protocols necessary for cleaning validation at the Boehringer & Ingleheim Chemicals, Inc. facility in Peterburg, VA.

As Validation Specialist 1 consultant, Mr. Lynch participated in the development and execution of IQ/OQ and PQ protocols and summary reports for a fermentation process and HVAC/facility systems for Cephalon, Inc., Beltsville Maryland.

As Validation Specialist 1 consultant, Mr. Lynch participated in the qualification development protocols for the HVAC and related equipment such as qualification protocols, summary reports and SOPs for the breast implant manufacturing process at the McGhan Medical facility in Santa Barbara, California

STRENGTHS AND SKILLS

Project management and related activities

Technical writing for validation documentation, personnel resumes for marketing purposes, etc.

Ability to write, implements prepares and executes, validation protocols, finalizing reports.

Keen sense-identifying deficiencies in auditing documentation.

Ability to generate business through direct contact and personal rapport with clients.

Ability to utilize communication skills and formulate plans for motivating customers to achieve objectives.

Effective leader with combination of strong technical aptitude and excellent administrative and decision making skills. Customer/public relation’s professional accustomed to positive results.

Good interpersonal relations and good communications skills. Leadership, quick learner, self-starter, team player, responsible, highly organized and dedicated with a positive attitude

Demonstrates the ability to handle multiple assignments during pressured situations

Mr. Lynch has participated in the following trainings:

• Clients -Current Good Manufacturing Practice /Safety Training (1995-2007)

• Day & Zimmermann- Good Documentation Practices (11/2007)

• Day & Zimmermann- The Basics of Understanding Programmable Logic Controls (PLCs) (06/2006)

• Day & Zimmermann- The Basics of Lyophilization (09/2005)

• Day & Zimmermann- Current Good Manufacturing Practice (12/2005)

• D&Z -Introduction to FDA Approach for Validation of Computerized Systems (Systems Life Cycle) (11/2002)

• AMA Workshop- Improving Your Project Management Skills: The Basics for Success (11/2000)

• PDA Workshop-The Basics of Master Planning Workshop (10/2005)

• Mistake-free Proof Reading/ Grammar Workshop (11/2000)

• ERC Computer Training-Lotus Notes 6.5 (08/2004)

Page 3

Completed the following courses via Internet Integrity Interactive at Work Seminars (2003-2006):

Integrity Interactive Courses Completed -Mutual Respect / Making A Deal/ Dangers of Cover Ups/Gifts and Conflicts of Interest/E-Compliance/Confidentiality/Antitrust/ Privacy Safety & Environmental In the Office / Financial Integrity / Intellectual Property / Protecting America / Privacy / Government Procurement/ Insider Trading/ Foreign Corrupt Practices Act/ Monopolization/ Information Protection

PROFESSIONAL AFFILIATIONS

• Member of Linked In Network since 2008

• American Management Association (AMA)

• Member of International Association for Pharmaceutical and Science Technology (PDA)

• Member of International Society of Pharmaceutical Engineers (ISPE)

EDUCATION

Spring Garden College, Philadelphia, Pa. Business Administration/ Construction Technology (1974-1975)

City University of New York (York College), Jamaica, New York - Business Administration (1975-1976)

Temple University, Ambler, Pa Liberal Arts (1976-1977)

REFERENCES- PROVIDED UPON REQUEST AND AT

http://www.linkedin.com/in/lynchgregory

Contact this candidate