Quality Control Assurance

WAYNE GOPAUL

** ******** ******, *********, ** **420

781-***-**** *.*.******@*****.***

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A challenging position as a Quality Packaging Engineer within the

Manufacturing/Pharmaceutical Industry

. Knowledge of the Regulatory, Quality Control and Quality Assurance

guidelines and experience working in a GLP, ISO and GMP environments

. Reviewing lab notebooks/reports, verifying that data meets current

specifications, test methods and assays for stability testing raw

material, In- Process, Microbiological Gram Stained, gel clots, cell

assays and final product testing

. Preparation of protocols: approval of deviations, Non-Compliance

reports, COA's/Lab reports, laboratory Investigation reports and

trending stability data

. Knowledgeable in cGMP requirements for drug/food supplement

development through marketable product, SOP authoring, generation,

editing, reviewing and approving

. Mentoring, scheduling and training of staff members, prioritizing

project timelines and product releases

. Analyzing, resolving and documenting test results, investigating Out

of Spec, Notice of Events, Non- compliance results and closing out of

documentation for product disposition

. Review of Annual Product, performed internal/external audits and

vendor approvals, Monitor stability test points and entering results

into QA database, and assembling QC data packages for product batch

file

. CAPA/OOS, accelerated stability studies, independent decision-making

and resolution of Quality issues

. Appropriation and distribution of controlled documents for QA/QC

procedures (data sheets, SOPs, Change, Work request and Investigation

forms)

PROFESSIONAL EXPERIENCE

GMP Consultant/Auditor (part-time) June

2008- Present

. Advise and consult on client interaction with Regulatory Agencies.

. Advise Client with requirements for Regulatory Compliance

. Assist with drafting of "Letter Of Intent" to Regulatory Agency

. Consult with Management to address impending issues and

recommendations

Amerifit Pharma, Inc. July 2005 -

June 2008

Quality Assurance / Quality Control/Regulatory Department

. Supervise all respective operations, decisions and mandated federal

requirements were performed for the release of finished products for

interstate commerce.

. Developed, maintained and coordinated with other departments a Quality

system with a high level of ICH, cGMP/GLP/ISO compliance in all

regulated activities

. Completed project support which includes dispositions of final API's

intermediates and raw materials, deviations/investigations, auditing

programs, review and approval of validation protocols, test method

enhancement and cGMP training

. Experienced with QA compliance issues associated with FDA and DEA

regulations

WAYNE GOPAUL

14 Boutelle Street, Fitchburg, MA 01420

781-***-**** *.*.******@*****.***

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~Continued~

. Oversee document control procedures for archiving and retrieving of

data

. Working knowledge of cGMP's and their documentation: able to work well

in a project team environment with strong abilities to develop

corporate regulatory strategy

. Experienced with method development, process validation creation and

equipment qualification protocols; (IQ, OQ, PQ), risk assessment and

assurance of regulatory conformance to applicable standards

Polymedica Pharmaceuticals Jan 1999 -

July 2005

Quality Assurance / Quality Control Specialist

. Developed, maintained and co-ordinated with other departments a

Quality system with a high level of ICH, cGMP/GLP/ISO compliance in

all regulated activities

. Completed project support which includes dispositions of final API's

intermediates and raw materials, deviations/investigations, auditing

programs, review and approval of validation protocols, test method

enhancement and cGMP training

. Experienced with QA compliance issues associated with FDA and DEA

regulations

. Oversee document control procedures for archiving and retrieving of

data

. Working knowledge of cGMP's and their documentation: able to work well

in a project team environment with strong abilities to develop

corporate regulatory strategy

. Experienced with method development, process validation creation and

equipment qualification protocols; (IQ, OQ, PQ), risk assessment and

assurance of regulatory conformance to applicable standards

. Maintained routine support of release, stability and in process

testing of raw materials, intermediates and finished products

. Maintained of cell culture cell lines, maintenance of cell pots and

spinners, preparation of media

. Performed investigations of QC/QA procedures, specifications,

qualifications, certifications and disposition of raw materials, in-

process and marketable products

. Excellent working experiences with cross-functional teams and

supervising a packaging staff of seven individuals

. Execution of validation protocols supporting Development and

Manufacturing department

. Experience in product test planning, documentation, and process

improvement

. Investigating, resolving and responding to customer inquiries

. Liaison between Sales Systems, Quality, Senior Management,

Manufacturing

. Maintained equipment, chemicals and the pest control program

. Proactively performs active audits within the manufacturing plant to

ensure real time cGMP compliance

WAYNE GOPAUL

14 Boutelle Street, Fitchburg, MA 01420

781-***-**** *.*.******@*****.***

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~Continued~

Nutramax Pharmaceuticals Feb 1998 -

Dec 1998

Quality Control Specialist

. Batch record, C.O.C/C.O.A's reviews

. Calibration of Lab Instruments/Equipment

. Quality testing of in-process products

. Training of new employees

Copley Pharmaceuticals Jan 1996 -

July 1998

Quality Control / Quality Analyst

. Quality Control testing of manufactured/stability products

. Quality testing of in-process products

. Assembly of testing kits, Quality Assurance of test kits

Abbott Labs/Repligen Pharmaceuticals 1995 - 1996

Quality Analyst /Quality Control Specialist

. Quality Control testing of manufactured products

. Batch record, Lab report reviews

. Evaluation of lab results, training of new employees

. Column Chromatography of small molecules

. Development of mammalian cell antibody molecules

. HPLC Protein assays

Professional Affiliation

Current member - ASQ (American Society of Quality)

Education

Bachelor of Science - Microbiology / Biotechnology

Framingham State College,

Framingham, MA

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