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General
About
Information Systems/Technology and Quality Manager with over 15 years of pharmaceutical experience managing projects
•Skilled at writing validation plans and reports, requirements traceability matrixes, user and functional requirements specifications, test plans and strategies, and test cases.
•Demonstrated knowledge in functional and non-functional testing
•Proven experience in project management principles and practices to deliver validated IT systems.
•Known for business process modeling, process re-engineering, continuous improvement and change management.
•Excellent ability to resolve critical issues during the validation of computerized systems and to build relationships with key stakeholders and across functional groups.
•Track record of delivering IT business solutions within specified timelines and to the satisfaction of key stakeholders.
•Demonstrated strengths include:
•Developing policies, procedures, and technical training
•Prac
•Skilled at writing validation plans and reports, requirements traceability matrixes, user and functional requirements specifications, test plans and strategies, and test cases.
•Demonstrated knowledge in functional and non-functional testing
•Proven experience in project management principles and practices to deliver validated IT systems.
•Known for business process modeling, process re-engineering, continuous improvement and change management.
•Excellent ability to resolve critical issues during the validation of computerized systems and to build relationships with key stakeholders and across functional groups.
•Track record of delivering IT business solutions within specified timelines and to the satisfaction of key stakeholders.
•Demonstrated strengths include:
•Developing policies, procedures, and technical training
•Prac
Haves
Business process re-engineering, System Implementation, Computer Validation, User Acceptance Testing, Training Development, Project Management, Quality Assurance
Professional Experience
Jul 2011 - Present
Owner
Pocrnic Consulting
Pharmaceuticals
Pocrnic Consulting
Pharmaceuticals
IT and Quality Professional specializing in Computer Validation and IT Compliance.
Experienced in writing User Requirements Specifications (URS), Functional Requirements Specification (FRS), Validation Plans and Reports, Test Plans and Strategies, Installation Qualification, Operational Qualification, and Performance Qualification Protocols, User Acceptance Test Cases (UAT), Incident and Deviations Reports, Change Management Requests, and System Retirement Plans and Reports.
Experienced in writing User Requirements Specifications (URS), Functional Requirements Specification (FRS), Validation Plans and Reports, Test Plans and Strategies, Installation Qualification, Operational Qualification, and Performance Qualification Protocols, User Acceptance Test Cases (UAT), Incident and Deviations Reports, Change Management Requests, and System Retirement Plans and Reports.
Oct 2011 - Present
QA Computer Validation Specialist
Apotex Pharmachem Inc.
Pharmaceuticals
Apotex Pharmachem Inc.
Pharmaceuticals
Developed and implemented the global Computer System Validation program.
•Chaired the Computer System Validation Working Committee meetings.
Facilitated user requirements gathering sessions for a data analysis software application and a cleaning calculator application.
Delivered a CSV workshop to key stakeholders in other departments.
Coordinated external training sessions on Validation of Excel Spreadsheets and the Validation of Legacy Systems.
Analyzed existing business processes and investigated solutions to improve efficiency and compliance, for example the Equipment Cleaning Process Provided QA support for change management process for GxP systems
Provided CSV expertise during Health Canada and FDA audits.
•Chaired the Computer System Validation Working Committee meetings.
Facilitated user requirements gathering sessions for a data analysis software application and a cleaning calculator application.
Delivered a CSV workshop to key stakeholders in other departments.
Coordinated external training sessions on Validation of Excel Spreadsheets and the Validation of Legacy Systems.
Analyzed existing business processes and investigated solutions to improve efficiency and compliance, for example the Equipment Cleaning Process Provided QA support for change management process for GxP systems
Provided CSV expertise during Health Canada and FDA audits.
Jan 1996 - Sep 1999
(3 years, 8 Months)
(3 years, 8 Months)
Analyst
GlaxoSmithKline
Pharmaceuticals
GlaxoSmithKline
Pharmaceuticals
Managed the lifecycle of laboratory equipment.
Performed scientific testing on drug products
Developed an excellent knowledge of scientific software
Produced data to support the delivery of new products to the market
Supervised a summer student
Member of the departmental health and safety committee
Performed scientific testing on drug products
Developed an excellent knowledge of scientific software
Produced data to support the delivery of new products to the market
Supervised a summer student
Member of the departmental health and safety committee
Sep 1999 - Sep 2007
(8 years)
(8 years)
IT Compliance Analyst
GlaxoSmithKline
Pharmaceuticals
GlaxoSmithKline
Pharmaceuticals
Prepared validation documentation and standard operating procedures for computerized systems.
Managed and coordinated local site activities during the implementation of different global software application.
Provided administrative support for mission critical software application and ensured these systems met regulatory requirements.
Implemented a Year 2000 strategy for mission critical business systems
Collaborated with an external vendor to improve the functionality of the vendor's application
Managed and coordinated local site activities during the implementation of different global software application.
Provided administrative support for mission critical software application and ensured these systems met regulatory requirements.
Implemented a Year 2000 strategy for mission critical business systems
Collaborated with an external vendor to improve the functionality of the vendor's application
Sep 2007 - Jul 2010
(3 years)
(3 years)
Principal IT Compliance Analyst
GlaxoSmithKline Inc
Pharmaceuticals
GlaxoSmithKline Inc
Pharmaceuticals
Led a cross functional and multi-national team that implemented a complex laboratory IT system
Directed the implementation of harmonized best practices across global sites
Worked with key stakeholders to develop business requirements
Developed project plans and test plans to ensure the timely delivery of the laboratory IT system
Coordinated and administered user acceptance testing
Developed computer based training modules in preparation for the deployment of the new laboratory IT system across multiple sites
Developed and delivered external training on computer validation
Directed the implementation of harmonized best practices across global sites
Worked with key stakeholders to develop business requirements
Developed project plans and test plans to ensure the timely delivery of the laboratory IT system
Coordinated and administered user acceptance testing
Developed computer based training modules in preparation for the deployment of the new laboratory IT system across multiple sites
Developed and delivered external training on computer validation
Jul 2010 - Aug 2011
(1 years, 1 Months)
(1 years, 1 Months)
IT Computer Validation Manager
Valeant Pharmaceuticals
Pharmaceuticals
Valeant Pharmaceuticals
Pharmaceuticals
Responsible for ensuring and maintaining compliance of all regulated systems at the corporate and manufacturing sites. Staff: 1
•Lead the integration of policies and standard operating procedures from the legacy Biovail and Valeant organizations
•Guided staff in developing requirements documents, validation protocols, and user acceptance test cases
•Mentored manufacturing, laboratory and IT staff on computer validation •Collaborated with Corporate IT to manage and improve the change control process for SOX and GxP systems
•Conducted software vendor audits
•Reviewed all documentation related to regulated computer systems
•Lead the integration of policies and standard operating procedures from the legacy Biovail and Valeant organizations
•Guided staff in developing requirements documents, validation protocols, and user acceptance test cases
•Mentored manufacturing, laboratory and IT staff on computer validation •Collaborated with Corporate IT to manage and improve the change control process for SOX and GxP systems
•Conducted software vendor audits
•Reviewed all documentation related to regulated computer systems
Education
2012
University of Toronto at Mississauga - Erindale College (High School)
2012
Sheridan College (High School)
Computer Programming
Computer Programming
1989
Hons BSC, University of Waterloo (High School)
Applied Chemistry
Applied Chemistry
2002
MMSc, University of Waterloo (High School)
Management of Technology
Management of Technology
More about David Pocrnic
First Name
David
Last Name
Pocrnic
Specialities
Business process re-engineering, System Implementation, Computer Validation, User Acceptance Testing, Training Development, Project Management, Quality Assurance
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