Director GMP Compliance/Metrology/Validation

IGOR SALISTRA

US Citizen Home: 1-650-***-****

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

Executive Profile

Accomplished Manager with demonstrated ability to deliver mission-critical results.

Skill Highlights

● Over twenty-two years of multi-national technical and management experience

● Fifteen years of pharmaceutical industrial experience in Process, Laboratory & Analytical Equipment Qualification and Validation (IQ/OQ/PQ/PV)

● Direct experience negotiating with International Governmental and Regulatory agencies

● Extensive experience in Quality Management, Process Excellence and Six Sigma.

● Proven ability to manage and mentor large teams of individuals across multiple shifts, multiple departments and multiple facilities.

Core Accomplishments

● Expert knowledge of quality management systems ISO-9001, cGMP, cGLP, Technical Trainings

● Extensive knowledge and experience in Metrology, Instrumentation, Industrial & Facility Engineering

● Excellent organization and project management skills with a demonstrated capability leading numerous projects from initial concept through feasibility studies, cost estimates and final process implementation

● Technical ability to generate Standard Operation Procedures (SOP), conduct Technical Investigations and DOE's, and develop Change Control Management processes

• 6 NPD introductions

• First in Russian Federation European “GMP Compliance Letter” of the Solid Dosage Form production lines

• 4 new tablet production lines with a total capacity of 26 million packs per month

• 1 new line for aerosols and sprays with a total capacity of 1 million packs per month

• Process Excellence project (Metrology Enhancement) saving $1,000,000 per year

• Optimized calibration procedures and intervals saving $230,000 per year

Professional Experience

GMP Auditor

September 2010 to Current

SQA Services – Los Angeles, CA

Contract

GMP Consultant

January 2008 to October 2010

Pharmstandard – Moscow , Russian Federation

Director GMP Compliance and Technical Development

June 2004 to July 2007

Pharmstandard – Moscow, Russian Federation

Director level position managing and coordinating the efforts of14 department managers and 480 engineers and specialists across 5 manufactories

● Developed business objectives, budgets, strategies, actions, process improvements and feedback/reporting mechanisms. Accountable for all of my departments' P&L.

● Development and implementation of the cGMP for all 5 of Pharmstandard's pharmaceutical manufactories.

● Directly responsible for the implementation of an integrated company-wide Quality Management System (ISO-9001, ISO-13485) based on best practices of leading global companies

● Oversaw all Validation activities

● Oversaw all new product development (NPD) from a process and quality perspective. Actively participated in cross-functional strategy sessions with marketing, finance and corporate directors regarding any new product development.

● Refined existing and developed new operational procedures to ensure optimum efficiency and effectiveness.

● Prepared facility plans and capital expense budgets to meet projected growth and technology targets

● Assumed full responsibility for regulatory inspections and collaboration with Russian Federal regulatory organizations.

● Maintained expected levels of performance in the Leadership Core Competencies within my 14 individual plant management teams. I coach individual excellence, an inclusive leadership style, an external focus, and routinely monitor performance.

Sr. Manager Metrology/Calibration & GMP Compliance Dpt.

February 2001 to June 2004

Alza Pharmaceutical Corp. – Mountain View, California

Senior Manager leading the Metrology/Calibration Department consisting of 30 in-house staff across two shifts, with a yearly departmental budget of $5.6 million dollars.

Full responsibility for departmental operations including staff development plans, performance reviews, financial objectives, budgets, purchases, cGxP and job-related training programs.

Responsible for execution of over 18,000 maintenance and calibration work orders per year for over 2,300 pieces of Process Equipment, 2,000 pieces of Analytical & Laboratory Equipment, 500 Scales & Balances, and 500 pieces of Test Equipment, following established company policies and cGMP/GLP/GCP guidelines.

• Responsible for the development, implementation and execution of Validation and Qualification Protocols (IQ/OQ/PQ/PV) for all metrology equipment. Improved the effectiveness of corporate and departmental policies and procedures resulting in sustainable compliance.

• Provided technical and management support to internal and external audits (both certification-based and regulatory agency)

• Responsible for the Quality Improvement (Process Excellence) Program

Manager GMP Compliance Dpt.

February 1995 to February 2001

Alza Corporation – Mountain View, California

• Directed the activities of Industrial Controls Engineers/Specialists across multiple shifts

• Responsible for the technical review of equipment work orders and test data for accuracy and cGMP/GLP compliance.

• Evaluated performance capabilities and specifications for Reference Standards and the Test & Measurement Equipment, in order to ensure the proper calibration frequency is assigned to each calibration procedure.

• Performed technical investigations on equipment for out of tolerance issues or project studies. Monitored departure records on ExRx software to ensure departure reports related to equipment maintenance and calibration are fully addressed and closed out in a timely manner.

• Prepared documentation for internal and external audits.

• Wrote, revised and implemented SOPs for new and existing Process Equipment.

• Performed Design of Experiment (DOE) studies for new equipment.

Plant Engineer

January 1993 to February 1995

Alza Corporation – Mountain View, California

Gained a wealth of knowledge and experience related to control and energy systems, safety compliance, building management systems, preventive maintenance, instrument calibrations, equipment troubleshooting, PID controls, and maintenance procedures.

Chief Engineer

December 1978 to December 1991

UkrPromRemNaladka – Kiev, Ukraine

Provided engineering leadership and direction to 20 engineers and specialists involved in design, development, installation, start-up, maintenance, repair, modification and upgrade of Automatic Control and Protection Systems. Designed Energy Management and Building Control Systems for manufacturing facilities, laboratories, offices and hotels

Education

National Technical University of Ukraine

Kiev, Ukraine, Ukraine

Electrical Engineering

MS

Keywords

QA, GMP/GLP/GDP, Metrology, Six-Sigma, Process Excellence, P&L, CAPEX, Qualification and Validation (IQ/OQ/PQ/PV), SOP, Quality Management, Change Control Management, CAPA

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