Quality Assurance Manufacturing

Wieslaw Rakoczy

** ***** ***** ***** 973-***-****

Vernon, NJ 07462

**********@*****.***

PHARMACEUTICAL MANUFACTURING AND QUALITY PROFESSIONAL

Experienced in Pharmaceutical Manufacturing, with proven track record as

Technical Expert, Manufacturing Supervisor and Quality Assurance Specialist.

Key Areas of Expertise

• Parenteral and Transdermal Drugs Manufacturing (LOC, OSD and Inhalants experience)

• Sterile Manufacturing Supervision, Training and Vendor Management

• Sterile Facility Sanitization and Building Management System

• cGMP Batch Record review, QA Monitoring and In-Process QA of packaging

• Finished product, materials and components disposition

• 3rd party manufacturing BR review and product disposition

SELECTED ACCOMPLISHMENTS

• Led Supervision of 2-nd shift sterile manufacturing operation, at Organon.

Cross-trained Technicians and effectively managed sanitizing vendor.

Contributed to improvements in Compliance and Productivity. Recognized for

assuring sterile manufacturing conditions, and no-loss handling of multi-

million-valued product.

• Shared awareness of capturing manufacturing parameters and professional

knowledge, needed for handling advanced equipment and manufacturing

techniques at LTS. Actions led to increased productivity and significant waste

reduction on shift.

• Successful QA Release Auditor at Merck, through extended responsibilities in

manufacturing (IPQA and QA Monitoring), utilizing experiences and technical

background. Significantly contributed to timely delivery of product to the

customer, by ensuring effective Batch Record review process, by being

flexible with work schedule and working overtime.

PROFESSIONAL EXPERIENCE

Independent Contractor of QualComp Consulting Services LLC June – Oct 2013

Engagement Client: Novartis Consumer Health, TPO, Parsippany – QA Support

• Updated TPO metrics reports – tracking complaint investigation process

• Updated Consumer Relationship Tracking System with Investigation Requests, Reports

and other complaint documentation

• Generated weekly product/lot complaints trend report

• Distributed incoming Investigation Reports to product teams

• Assured completeness and interdependence of documentation/information collected and

attached

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• Participated in improvement effort of Complaints review and trending process

• Supported TPO Batch Review team

Schering Plough / Merck - (Pharmaceuticals), Kenilworth, NJ May 2008 – Dec 2012

QA Release Auditor/Specialist, QA Batch Release

• Accountable for batch documentation cGMP review, QA monitoring and IPQA activities

• Approved all product materials and components utilizing LIMS, SAP, QAS and TrackWise

software

• Reviewed and approved commercial, validation, and study batches manufactured on-site,

by

3rd party, or affiliate manufacturers

• Implemented documentation corrections from manufacturing, packaging, laboratory, and

QC services

• Identified nonconformities, tracked significant errors and issues, and provided input for

investigations

• Collaborated with Validation and Quality Engineering departments, providing cGMP

documentation review

Akzo Nobel, Organon USA Inc., / Organon Biosciences, West Orange, NJ Jun 2001 – May

2008

Technical Specialist, Quality Affairs, Release Coordination (Sep 2004 –May 2008)

• Reviewed CMO Batch Manufacturing Records of marketed and clinical drugs, to assure

conformance

with CMO and cGMP procedures

• Interacted with CMO QA personnel remotely and on-site, to resolve documentation/procedural

issues

• Revised Batch Master Records and SOP documentation for CMO QA via Quality Assurance

and

Product Outsourcing Departments

• Tracked KPI’s, categorized and trended MBR review observations designated for CMO

Supervisor, Sterile Production Department (Feb 2002 – Sep 2004)

• Supervised production activities of 8-12 technicians in parenteral production facility, with

responsibility for preparation and sterilization of process parts and components,

depyrogenation, cleanroom sanitization, glassware inspection and terminal sterilization of

product

• Monitored production equipment locally and remotely, including glassware washers, CIP

system, vial stopper processors, autoclaves, dry heat ovens, vial dryers, refrigerators, freeze

dryers, BMS differential pressure system (24/7). Reviewed daily logs and charts with process

data

• Analyzed technical issues with equipment and issued Work Order requests

• Revised SOP, and provided critical input to Corrective and Preventative Action investigations

• Managed an external Sanitizing Contractor, including resolution of issues

• Awarded in Cost Awareness Program (FIFO), contributed to technical/production process

improvements (Compliance and Productivity), and cross functional training of Technicians

Production Technician III, Sterile Production Department (Jun 2001 – Feb 2002)

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• Prepared, set, and operated product filling and filtration equipment, autoclaves, dry heat

ovens and vial washers

• Compounded drug products

• Provided input to SOP revisions and updates

Lohmann Therapy Systems, (Pharmaceuticals), West Caldwell, NJ Sep 1999 – Jun

2001

Pharmaceutical Production Technician, Coating and Laminating Department

• Operated “Roll-over-Roll” and “Reverse Roll” coaters (web handling)

• Specialized in operating an applicator section (coating head), producing components for

Transdermal and Oral Drug Delivery Systems, and industrial applications (Gore-Tex)

• Participated actively in product development, equipment repairs and maintenance jobs

Lamart Corporation, Clifton, NJ Feb 1998 –

Sep1999

Production Supervisor, Coating and Laminating Department

• Supervised 1-st shift production with several technicians, utilizing Reverse Roll, Reverse and

Offset Gravure, Doctor Blade, UV, and Corona surface treatment techniques (web

handling/converting)

• Supervised 4-5 technicians and production process with specialized equipment, within

development process of new generation, polymer-based, Lithium-Ion batteries

• Contributed to production process improvement and In-Line Quality Control activities, using

measuring tools, Gamma Gauge system, CCD cameras, scales, viscometers and tensile

testers

EDUCATION & PROFESSIONAL TRAINING

Six Sigma, Yellow Belt – Merck 2011

GMP Compliance for QC Laboratory Operations – PharmaNet 2007

Complying with cGMP and GMP Requirements, Adv. Level – PTi 2007

GMP Compliance Auditing – PharmaNet, Inc. 2006

Conducting Batch Record Reviews and Investigations – PTi 2006

Montclair State University, Montclair, NJ, USA (selected courses completed: English, Math,

Macro Economy, Speech Communication)

Technical/Mechanical School, Poland – Diploma

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