Quality Assurance Manufacturing

Karel Nicolas

** ****** *** ******** ** *****

CELL Phone 917-***-**** Home 516-***-****

SUMMARY

MS Degree in Energy Management with a Certificate in Facility

Twenty years in the Pharmaceutical Industry Management

Seven Years of Project experience, supervised complete validation and continuous improvement projects.

Excellent people and project skills. Work well within cross-functional teams with management, Engineering, IT, Quality and production personnel.

Computer Skills:

Windows XP 2000, AutoCAD, Micros oft Office 2000, Ms Word, Excel, Ms Access

PROFESSIONAL EXPERIENCE

Edwards Life Science 09/2014 – 09/2015

Wrote and Executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for various packaging validation equipment. assists in development of training document and Standard Operation Procedures (SOPs)

Prepare Interim and final validation reports

Kedrion Pharmaceuticals Inc. 07/2013 – 07/2014

Validation Specialist (Contract)

Prepare and review equipment qualification protocols for IQ/OQ/PQ

Write and review summary reports for the various equipment qualification

Schedule and coordinates validation activities with affected departments

Executes validation protocols, assists in development of training document and Standard Operation Procedures (SOPs)

Prepare Interim and final validation reports

Fougera Pharmaceuticals Inc. 05/2013 – 09/2013

Validation Specialist (Contract)

Prepare and review equipment qualification protocols for IQ/OQ/PQ

Write Execute and approved protocols while working in conjunction with the engineering, Operations and QA/QC Departments as appropriate.

Schedule and coordinates validation activities with affected departments

Executes validation protocols, assists in development of training document and Standard Operation Procedures (SOPs)

Prepare Interim and final validation reports

Perrigo 08/2011 – 04/2013

Validation Specialist (Contract)

Prepare and review equipment qualification protocols for IQ/OQ/PQ

Write Execute and approved protocols while working in conjunction with the engineering, Operations and QA/QC Departments as appropriate.

Provide assistance to operation personnel in the development of SOP’S as needed.

Write and review summary reports for the various equipment qualification

During Process validation studies monitor both compounding and packaging operations as necessary to ensure conformance with approved protocols and procedures.

Review in-process documentation and report any deviations/concerns to the validation department manager and QA department.

Review and approve validation sampling records and QA physical testing results

Coordinate the timing of the cleaning and swab sampling activities with the appropriate Operation, QA and Laboratory personnel.

Oversee and document the swab sampling operation.

Pfizer 02/2011 – 07/2011

Lead Investigator (Contract)

Perform manufacturing investigations for the Pneumococcal Polysaccharide Production department by researching, solving, and tracking manufacturing discrepancies and initiating resulting commitments.

Gather and review validation and batch documentation, SOPs, testing and manufacturing specifications, test results, training and calibration records, and regulatory policies.

Write investigation summaries, product impact assessments, root cause analysis, corrective actions, and commitments using the SAP-CAPA system.

Ensure that manufacturing investigation reports accurately identify all processing and manufacturing deficiencies to determine and classify root causes.

Medtronic 09/2010 – 12/2010

Validation Engineer (Contract)

Documented cleaning activities for product lines in machining, metal finishing and assembly operations; worked with shop employees and quality personnel.

Managed changes in manufacturing methods, processes and Manufacturing Process Planning documentation based upon the cleaning validation strategy.

Executed and documented all changes through the Manufacturing Engineering process control system.

Initiated improvements in current manufacturing methods and process to improve part quality/ product cleanliness.

Initiated, controlled and executed validation processes and procedures for engineering as required by the FDA and other medical device regulatory systems

IMDS (Innovative Medical Device Solution) 02/2010 – 08/2010

Validation Specialist (Contract)

Provide Validation and Quality Assurance Services to support the manufacture of drug and medical device products. Wrote and executed validation protocol for clean-lines for medical devices and instruments.

Clients include:

Wrote and Executed Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification Clean-Lines, Compressed Air, RO/DI Water System, Hai Tech Laser Hetc

Provide Validation Services to support manufacture of drug and products. Wrote and executed validation protocol for Manufacturing Area Qualification and Manufacturing instruments.

OHM Laboratories Inc 08/2009 – 02/2010

Validation Specialist (Contract)

Wrote and Executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for : I pure Water System, Air Handler: AHU 61, Mogensen: Mechanical Sifter, High Shear Mixer Granulator (PMA 600), Fluid Bed Processor Equipment Make: Niro Inc Model: MP-6, Area Qualification for processing Room Corridors and Wash Room, 100 CDM Cubic foot twin or Blender

Orthopedic, Mahwah NJ 03/2008 – 03/2009

Validation Specialist (Contract)

Executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of medical device cleaning equipment

Ensured company met FDA regulations by authoring protocol and procedures for clean-line validation and operational settings

Performed gap analysis of clean-line equipment in accordance to Master Validation Plan

Designed guide sheets to ensure good quality assurance practices were used for the design of the company’s devices

Ensured guide sheets were consistent with quality system requirements as per FDA requirements

Assured GMP compliance by thoroughly inspecting packaging lines daily

Verified efficacy parameters for routine processing of medical instruments and implants

Johnson & Johnson, Rockford Chicago 07/2007 – 02/2008

Quality Specialist (Contract)

Enabled major product to transition from RX to OTC by providing on-site validation of contract packaging operation

Permitted product to be sold in seven different packaging configurations (blisters, bottles, pouches, clamshells, etc.) by reviewing and approving all validation documents (IQ, OQ, PQ and PV)

Ensured that product met FDA standards by reviewing and approving executed batch records

Pfizer, Brooklyn, NY 10/1995 – 07/2007

Validation Specialist

Wrote and executed Installation, Operation, Performance and Validation Protocols for the facility. This included manufacturing systems and equipment and operation support systems. Regularly interacted with key Manufacturing personnel

Led the periodic Review Program for the Validation Team of this 1200 employee, 24-7, Oral Solids Dosage Manufacturing Plant.

Ensured that manufacturing equipment and systems operated according to established standards despite the incremental and cumulative changes that occurred over time by performing periodic reviews.

Performed an average of 140 Periodic Review Reports annually for validated Equipment /Facilities/Utilities related to the manufacture and Packaging of Oral Solid Dose products.

Key member of a Validation Project Team that assisted in the qualification of several critical projects such as: Kanebo Inspection System and Sortomat Sorter Tablet Laser Driller.

Maintained compliance with FDA Validation Master Plan requirements by reviewing and updating equipment as necessary.

Selected by Management to participate on the Quality Assurance Appraisal Team which audited various departments to assure compliance with established corporate and regulatory procedures.

Quality Assurance Technician

Inspected all packaging components to assure maintenance of standards stipulated by both GMP regulations and the FDA.

Ensured that all packaging components met specifications before use on the packaging line by performing various test procedures.

Calibrated measuring equipment using high precision micrometers and gauges.

Quality Assurance Inspector

Monitored packaging and manufacturing operations by performing inspections and weight and volume testing to insure product quality and by correcting any anomalies

Assured regulatory compliance by preparing and submitting Record of Inspection and Lot related information to the FDA.

Inspected, staged, and verified packaging components and material shipments for Clinical Supply Operation.

Performed line clearances and line monitoring for manufacturing and packaging module.

EDUCATION

Master of Arts, Energy Engineering

New York Institute of Technology; Old Westbury, NY

Bachelor of Science, Mechanical Engineering

New York Institute of Technology; Old Westbury, NY

PROFESSIONAL DEVELOPMENT

Six Sigma Green Belt

A+ (PC Technician)

CCNA (CISCO Certified Administrator)

MCSE (Microsoft Certified System Engineer)

CCNP (CISCO Certified Professional)

Facilities Management

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