SUMAN KANTHASAMY
Stouffville,Canada
Summary
Talented professional brings proven abilities in end-to-end project management. Expert in identifying and mitigating risks, reaching milestones, and managing deliverables. Highly organized leader with great attention to detail.
Overview
23
23
years of professional experience
Work History
Project Leader, Change Control Management (QS9)
Apotex Inc.
10.2023 - Current
- Assesses Change Control Record (CCR) documentation for accuracy and compliance to SODs and GMP
- Assesses impact of change (Functional Areas, Controlled Documents, markets, master data, etc.) and ensures all aspects of the change have been considered
- Reviews details of change to determine if the change concurs with the proposed strategies and appropriate implementation tasks are created.
- Review the assessments provided by the impacted Functional Area to determine if a formal risk assessment is required and if the appropriate actions have been identified to mitigate all potential risks
- Signs off as QA Responsible to execute change in QMS Trackwise.
- Facilitate cross-functional discussions ensuring all items on the agenda have been discussed
- Supporting Regulatory / customer / Self Inspection Audits by perform SME role for Change Control Management / SOD Change management supporting
- Provides coaching / feedback to the business to raise awareness of the change impact.
- Track and communicate performance metrics/scorecard to the site
- Assists in responding to customer requests for information as routed to the site through External Manufacturing Quality
- Continue to support SOD Change Management with all Documentation Change associated tasks
- Liaise with Global Quality and centralized group and supervise execution of activities related to assessment, adoption and implementation of global policies and procedures at site level
- Review MMaR / MPaR as part of CCR review
Supervisor, Documentation Management, Quality Systems Eto
Apotex Inc.
09.2021 - 10.2023
- Supervise the activities related to process, systems and people of QA Documentation Management within the Quality System management Eto Functional area
- Schedule, assign and follow-up on the work required according to departmental schedules and provide supervision / support to Associates in the performance of their daily duties.
- Interact with all GMP departments within the business to ensure all documentation requests are completed in timely manner to meet business needs
- Establish and maintain efficient and compliant documentation management processes
- Develop, implement and support process improvement initiatives
- Act as a technical source and coach for the business units and internal and external stakeholders and affiliates in regards to activities related to documentation management
- Respond to the enquires from other functional areas regarding documentation management effectively and efficiently
- Oversee the satisfactory resolution of the issues related to the documentation management
- Liaise with Global Quality and centralized group and supervise execution of activities related to assessment, adoption and implementation of global policies and procedures at site level
- Monitor execution and due dates, documentation review and approval at the site level, reporting and follow-up activities
- Understand and communicate corporate and site objectives
- Ensure departmental, team and corporate performance targets are achieved and monitor progress towards these target
- Prepare daily/ monthly activity reports and any statistical evaluation as requested by management.
- Performs the QA Responsible role of Change Control Management
Project Leader, Change Control Management (QS9)
Apotex Inc.
01.2020 - 09.2021
- Assesses Change Control Record (CCR) documentation for accuracy and compliance to SODs and GMP
- Assesses impact of change (Functional Areas, Controlled Documents, markets, master data, etc.) and ensures all aspects of the change have been considered
- Reviews details of change to determine if the change concurs with the proposed strategies and appropriate implementation tasks are created.
- Review the assessments provided by the impacted Functional Area to determine if a formal risk assessment is required and if the appropriate actions have been identified to mitigate all potential risks
- Signs off as QA Responsible to execute change in QMS Trackwise.
- Facilitate cross-functional discussions ensuring all items on the agenda have been discussed
- Supporting Regulatory / customer / Self Inspection Audits by perform SME role for Change Control Management / SOD Change management supporting
- Provides coaching / feedback to the business to raise awareness of the change impact.
- Track and communicate performance metrics/scorecard to the site
- Assists in responding to customer requests for information as routed to the site through External Manufacturing Quality
Project Leader, Change Control Management (QS8)
Apotex Inc.
03.2017 - 12.2019
- Assesses Change Control Record (CCR) documentation for accuracy and compliance to SODs and GMP
- Assesses impact of change (Functional Areas, Controlled Documents, markets, master data, etc.) and ensures all aspects of the change have been considered
- Reviews details of change to determine if the change concurs with the proposed strategies and ensures change owner has assigned appropriate implementation tasks and order of execution.
- Review the assessments provided by the impacted Functional Areas to determine if a formal risk assessment is required and if the appropriate actions have been identified to mitigate all potential risks
- Works with change owner as applicable to ensure execution of the implementation plan.
- Signs off as QA Responsible to execute change in QMS Trackwise.
- Facilitate cross-functional discussions ensuring all items on the agenda have been discussed
- Supporting Regulatory / customer / Self Inspection Audits by perform SME role for Change Control Management / SOD Change management supporting
- Provides coaching and feedback to the business to raise awareness of the change impact.
- Track and communicate performance metrics/scorecard to the site
- Assists in responding to customer requests for information as routed to the site through External Manufacturing Quality
Associate, Documentation Management
Apotex Inc.
02.2015 - 02.2017
- Review and provide assessment of new and revised Master Production & Packaging Documents in QMS Trackwise
- Approve Master Packaging Documents in Content Server
- Participate in the development and revision on site documentation
- Provide assistance to the change owners on requirements for initiating and completing change control packages related with Master documents
- Provide oversight and execute controls to ensure the accuracy, integrity, availability and legibility of documents
- Provide Quality System Documentation oversight on throughout the documentation lifecycle to assure that the changes to existing documents
Document Reviewer, QA In-Process
Apotex Inc.
11.2007 - 12.2011
- Review Manufacturing and Packaging Documents
- Review Master documents
- Perform Results Recording in SAP and LIMS
- Review all manufacturing and packaging in-process testing worksheets prior to final release
- Audit, archive & retrieve manufacturing and packaging logbooks
Coordinator, QA Product Release
Apotex Inc.
09.2006 - 10.2007
- Review and prepare checklist for Manufacturing and Packaging documents for final release.
Technician II, QA In-Process
Apotex Inc.
02.2004 - 08.2006
- Auditing and reviewing Manufacturing and Formulation Development documentations
- Creating and Developing the Quality Notification and the F-Notification using SAP system for any non-Conformance results
- Monitoring and arranging the calibration/recalibration of all QAIP testing equipment
- Communicating daily updates to the other teams and QAIP supervisor for any in-process issues
- Assist in the re-sampling, re-testing and investigating the Root cause for any non-conformance during in-process testing
Technician I, QA In-Process
Apotex Inc.
05.2002 - 02.2004
- Involved in Micro sampling for various products
- Performing Swabs for various products on various type of equipment
- Performing investigation for out of specifications results
- Reviewing Manufacturing and Packaging documents and protocols
Education
Chemical Laboratory Technology - Pharmaceutical
Seneca College of Applied arts and Technology
North York, Ontario12.2000
Skills
- Highly motivated, confident and mission-oriented professional in the Pharmaceutical industry with extensive knowledge / experience in Quality System and Quality Operations
- Trained in GMP and understands and apply FDA, HPFBI and EU GMP regulations and guidelines
- Excellent Customer service skills with proven ability to efficiently communicate with internal customers
- Very good knowledge in Microsoft Office (Word, Excel), LIMS, Power Point, QMS Trackwise, GLMS, SAP
- Certified in Lean Six Sigma Yellow Belt
- Able to review MMaRs and MPaRs
References
References will be provided upon request
Timeline
Project Leader, Change Control Management (QS9)
Apotex Inc.
10.2023 - Current
Supervisor, Documentation Management, Quality Systems Eto
Apotex Inc.
09.2021 - 10.2023
Project Leader, Change Control Management (QS9)
Apotex Inc.
01.2020 - 09.2021
Project Leader, Change Control Management (QS8)
Apotex Inc.
03.2017 - 12.2019
Associate, Documentation Management
Apotex Inc.
02.2015 - 02.2017
Document Reviewer, QA In-Process
Apotex Inc.
11.2007 - 12.2011
Coordinator, QA Product Release
Apotex Inc.
09.2006 - 10.2007
Technician II, QA In-Process
Apotex Inc.
02.2004 - 08.2006
Technician I, QA In-Process
Apotex Inc.
05.2002 - 02.2004
Chemical Laboratory Technology - Pharmaceutical
Seneca College of Applied arts and Technology
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