Summary
Overview
Work History
Education
Skills
Communication Skills
Leadership Experience
Timeline
Generic

Cindy Kaisersingh

Bradford

Summary

Highly experienced pharmaceutical professional with over 24 years in the industry, specializing in Quality Management Systems (QMS), regulatory compliance, and Manufacturing Science and Technology. Proven track record in delivering protocols, reports, and software updates. Expertise in SOP creation/revisions, Change Controls, and Deviations. Demonstrated leadership as the main compliance lead at Apotex Inc., overseeing global documentation management, system remediation, and alignment with regulatory requirements. Proficient in validation procedures, cGMP, 21 CFR Part 11, and change management processes. Strong technical resource, driving improvements in QMS and document management systems, while mentoring cross-functional teams. Experienced in managing internal and external audits, driving global quality initiatives, and ensuring timely validation testing and process improvements. Committed to producing high-quality work and aligning organizational goals with compliance and regulatory standards.

Overview

24
24
years of professional experience

Work History

Project Leader, MS&T-Process Validation

Apotex Inc.
07.2015 - Current
  • Integral part of the Livelink to Content Server upgrade project
  • Evaluation of PACE system for the Stage 3B Automation
  • Project managed the update, creation and discontinuation of over 2000 projects within PACE
  • Project management of CPV projects within EPM and MS Project
  • Implemented PACE system in ARPL (India Site) in March 2018
  • Maintenance of the design document for PACE which interfaces with SAP and LIMS finished product data
  • Created multiple benchmarking protocols based on statistical information for finished products
  • Review and execution of Stage 3A protocols and reports
  • Creation and execution of 140 test cases for changes applicable to PACE
  • Recommend and Initiate to SOPs Process Validation and PACE Software
  • Template creation for all business users for PACE
  • Creation of user roles and profiles for QMS and PACE
  • Trained in Level I & Level II Lean Sigma: Advanced Statistical Analysis
  • Trained in Quality Risk Management
  • SME for the PACE software and Process Validation during Audits
  • Generation of Stage 2 protocols and reports for new and existing product
  • Completion of Change Control Assessments for Stage 2

Project Leader, New Product Launch

Apotex Inc.
10.2008 - 07.2015
  • Initiated and managed over 160 CCRs for Launches to Commercial scale
  • Created, routed and delivered over 900 Demonstration and Validation Master Manufacturing Records and Master Packaging Records
  • Initiated and managed over 75 F-Notifications (Planned Deviation) for changes related to New Product Launches
  • Assisted the TSS team with the creation of Demo documents and Validation documents for legacy products
  • Attended PCM and relevant meetings to provide updates on the projects
  • Coordination of activities with other groups to ensure launches were successful
  • Reviewed Technical Transfer Protocols (TTPs) and Technical Transfer Reports (TTRs) for accuracy
  • Coached and trained technical writers on new processes, documentation and multiple timeline achievements

Technical Writer, Standard Operating Documents

Apotex Inc.
08.2005 - 09.2008
  • Manage specific departments Standard Operating Documents
  • Execution of SODs using Broadvision and Livelink
  • Monthly metrics on SOPs bi-annual review
  • Liaise with department managers on needs of SOP creations, revisions and cancellations

Level 5 Technician, Coating and Dosing Departments

Apotex Inc.
08.2001 - 08.2005
  • Execution of batch records to produce tablets and coat products, use of various tablet presses, coating pans and coating guns
  • Set up, start-up of tablet presses and coating pans
  • Dispense and reconcile materials for coating solution preparation
  • SOPs, cGMP, GDP compliance

Education

Diploma - PHARMACEUTICAL MANUFACTURING TECHNOLOGY

Toronto Institute of Pharmaceutical Technology
Toronto, ON

Trainer Qualifications and Presentation Skills - Lean Sigma: Advanced Statistical Training, Quality Risk Management, Annual GMP updates and Trends

Apotex Inc
Toronto, ON

Bachelor of Science - Health Administration

Athabasca University
Athabasca, AB
03.2025

PROJECT MANAGEMENT Professional - accreditation

PROJECT MANAGEMENT INSTITUTE
03.2025

Skills

  • GLMS Administration
  • Enterprise Super User
  • Process Analysis
  • Capability Enterprise
  • Process Validation Lifecycle
  • QMS Trackwise
  • Change Controls
  • Deviations
  • Lead Investigator
  • VITALs

Communication Skills

  • Delivering presentations on trending products in PACE.
  • Updating and delivering training for new users to the PACE system.
  • Employee Representative for Process Validation for the past 4 years.

Leadership Experience

Lead trainer for all modules of PACE software and designated trainer for all modules of QMS Trackwise for Change Control Creation, Implementation and Execution.

Timeline

Project Leader, MS&T-Process Validation

Apotex Inc.
07.2015 - Current

Project Leader, New Product Launch

Apotex Inc.
10.2008 - 07.2015

Technical Writer, Standard Operating Documents

Apotex Inc.
08.2005 - 09.2008

Level 5 Technician, Coating and Dosing Departments

Apotex Inc.
08.2001 - 08.2005

Diploma - PHARMACEUTICAL MANUFACTURING TECHNOLOGY

Toronto Institute of Pharmaceutical Technology

Trainer Qualifications and Presentation Skills - Lean Sigma: Advanced Statistical Training, Quality Risk Management, Annual GMP updates and Trends

Apotex Inc

Bachelor of Science - Health Administration

Athabasca University

PROJECT MANAGEMENT Professional - accreditation

PROJECT MANAGEMENT INSTITUTE

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