• Overall responsibility to lead and manage all Qualification and Validation activities of Pancap Pharma Inc.• Provide managerial oversight to internal departments and outside contractors / vendors of all necessary Validation / Qualification / Commissioning activities related to the facility, critical systems / utilities, equipment, manufacturing processes and cleaning procedures.• Lead, integrate and project manage multiple Validation priorities.• Prepare/Approve/Review Validation… Show more • Overall responsibility to lead and manage all Qualification and Validation activities of Pancap Pharma Inc.• Provide managerial oversight to internal departments and outside contractors / vendors of all necessary Validation / Qualification / Commissioning activities related to the facility, critical systems / utilities, equipment, manufacturing processes and cleaning procedures.• Lead, integrate and project manage multiple Validation priorities.• Prepare/Approve/Review Validation Master Plans and Schedules, Validation & Qualification Protocols / Reports, Change Control documentation, Standard Operating Procedures, review and evaluate Validation data.• Environmental Monitoring and Cleaning Validation Program.• Manage Temperature and Humidity Mapping Program.• Participate in Self-Inspection program.• Assist in regulatory audit preparation and inspector interaction.• Conduct SOP and GMP training when applicable. Show less

• Overall responsibility for the management and execution of the INTL Validation / Qualification Program (and Jamieson multi-sites as required) in compliance with corporate / legislative guidelines and the Validation Master Plan.• Provide managerial oversight to the Validation Team, internal departments and outside contractors / vendors directing the compliant design of all necessary Validation / Qualification / Commissioning activities related to the facility, critical systems / utilities,… Show more • Overall responsibility for the management and execution of the INTL Validation / Qualification Program (and Jamieson multi-sites as required) in compliance with corporate / legislative guidelines and the Validation Master Plan.• Provide managerial oversight to the Validation Team, internal departments and outside contractors / vendors directing the compliant design of all necessary Validation / Qualification / Commissioning activities related to the facility, critical systems / utilities, equipment, manufacturing processes and cleaning procedures.• Lead, integrate and project manage multiple Validation priorities simultaneously from initial concept through to successful implementation and completion adapting to changing business needs in a dynamic corporate environment.• Prepare/Approve/Review Validation Master Plan and Schedule, Validation & Qualification Protocols / Reports, Change Control documentation, Standard Operating Procedures, review and evaluate Validation data.Key Accomplishments:o Consistently managed the Validation Master Plan Project Schedule at > 97% on-time completion.o Project Lead for the development and implementation of the corporate Root Cause Analysis Training Program.o Project Lead for the internal development and implementation of a web-based Change Control System application and external scoping of a web-based Quality Management System software application.o Driving continuous improvement / process optimization opportunities such as implementation of the DocuSign electronic signature document approval process, Gamajet automated tank cleaning process. Show less

• Management of the Complaints Handling process – receipt, investigation, documentation and completion of Customer Medical and Technical complaints within CIBA VISION Site and Global metrics.• Perform complaint follow-up to ensure implementation and effectiveness of Corrective and Preventative Actions (CAPAs) resulting from complaint trends.• Completion of Annual Product Reviews and monthly, semi-annual, annual Complaint Trend Analyses for Novartis Ophthalmics, CIBA VISION Global and… Show more • Management of the Complaints Handling process – receipt, investigation, documentation and completion of Customer Medical and Technical complaints within CIBA VISION Site and Global metrics.• Perform complaint follow-up to ensure implementation and effectiveness of Corrective and Preventative Actions (CAPAs) resulting from complaint trends.• Completion of Annual Product Reviews and monthly, semi-annual, annual Complaint Trend Analyses for Novartis Ophthalmics, CIBA VISION Global and Third Party Customers.Key Accomplishments:o Managed the continuous improvement of the monthly complaint investigation on-time completion rate from 65% to > 95% and continued sustainability through process improvement initiatives.o CIBA VISION Global Quality Improvement Project – Blue Chip Team-Complaints – Site representative, Site CAPA team member. Show less

ValidationCoordinated the planning and execution of all validation / qualification projects as part of the Validation / Qualification Program.Prepared and revised corporate Validation Master Plans, site Validation Strategies & Schedules.Prepared and executed protocols, wrote interim / final reports, revised SOPs and other formal documents for the documentation system as required, consistent with cGMP requirements.Reviewed / approved qualification and validation protocols… Show more ValidationCoordinated the planning and execution of all validation / qualification projects as part of the Validation / Qualification Program.Prepared and revised corporate Validation Master Plans, site Validation Strategies & Schedules.Prepared and executed protocols, wrote interim / final reports, revised SOPs and other formal documents for the documentation system as required, consistent with cGMP requirements.Reviewed / approved qualification and validation protocols, completed data packages and final reports as required.Provided internal technical support in designing of experiments and executed necessary studies to improve product quality, lower product cost and optimize process efficiency.Change ControlManaged the cGMP Change Control program ensuring compliance to Health Canada, FDA and internal policies and procedures with respect to changes to products, manufacturing and cleaning processes, facility, equipment and utilities systems, analytical testing methodologies and computer hardware and software.Performed initial technical review of proposed changes, administration of in-process change requests and ensured all change projects are executed, completed, documented and closed out in a compliant and timely manner.Project Lead for the development and implementation of a web-based Change Management application providing real-time on-line submission, monitoring, tracking and metrics reporting of departmental Change Projects.Managed the reduction of total overdue Change Projects by 75% through periodic departmental meetings and project planning guidance.Customer ComplaintsAssisted in the management of the Customer Complaint program. Conducted preliminary assessments, assigned to an investigation leader, monitored investigation progress, prepared and submitted final response letters to Customers.Managed the reduction of total overdue Customer Complaint Investigations by 50% through periodic departmental meetings and project planning guidance. Show less

• Prepared, reviewed and implemented corporate policies and procedures and performed cGMP training.• Performed Internal / External Audits (Self-Inspections, Internal Compliance Evaluations, Internal Quality Assurance Inquiries and Consumer Complaint Investigations, Vendor Qualification).• Managed the overall Year 2000 (Y2K) Readiness Program.• Performed analytical testing of raw materials and in-process bulk, prepared and implemented Quality Control SOPs, reviewed and revised… Show more • Prepared, reviewed and implemented corporate policies and procedures and performed cGMP training.• Performed Internal / External Audits (Self-Inspections, Internal Compliance Evaluations, Internal Quality Assurance Inquiries and Consumer Complaint Investigations, Vendor Qualification).• Managed the overall Year 2000 (Y2K) Readiness Program.• Performed analytical testing of raw materials and in-process bulk, prepared and implemented Quality Control SOPs, reviewed and revised testing specifications as required.Key Accomplishments:o Developed and implemented the Quality Management System and Vendor Management Portfolio.o Successful Y2K transition without any major disruptions to the business.o Developed and implemented Calibration \ Preventative Maintenance Programs. Show less