1. HANSA THAKORE Home: (905) 660-9248 Cell: (647) 969-9248
88 Mabley Crescent, Thornhill, Ontario, L4J 2Z8 E-mail: thakore.hansa905@gmail.com
Objective: To grow my career in the Pharmaceutical Industry by gaining diverse experiences in Quality Assurance
PROFILE AND SKILLS
➢ A competent pharmaceutical professional with extensive experience within the quality assurance, formulations, research
and development and clinical areas for solid dosages (tablets and capsules), IV drugs (injectable, biological drugs),
parenteral nutrition, colloids, compounding solutions, standard solutions and transfusion technology
➢ In-depth knowledge of cGMP, GMP, GLP, ISO, USP, EP, BP, ICH and BGTD regulations to meet FDA, HPB, ISO
and MRA requirements.
➢ Master’s degree in microbiology which is equivalent to a Canadian B.Sc and a post graduate diploma in quality assurance
in pharmaceutical technology
➢ Ideally suitable to accurately audit and manage all stages of pharmaceutical production from development to submission
➢ Extensive knowledge of TrackWise System; including writing and approving deviations, action plans, complaints, as
well as recommending corrective and preventative actions (CAPA)
➢ Wrote detailed documentation such as SOPs, work instructions, technical manuals and protocols
➢ Excellent knowledge of the practical application of SAP software (Enterprise Resource Planning Software)
➢ Competed ISO 9001:2008 Course
PROFESSIONAL EXPERIENCE
Fresenius Kabi Canada Ltd, Richmond Hill ON 2010–Present
Quality Assurance/Quality Control Product Release Analyst
➢ Responsible for reviewing and releasing executed batch documents including: Finished Product Certificate of Analysis
(FP C of A), Active Pharmaceutical Ingredient (API) C of A, test results, manufacturing and packaging batch records
➢ Ensured release records were within guideline specifications and investigated and responded to any issues which arose
with testing laboratory, fabricators and warehouse
➢ Assessed the awaiting implementation forms for product specific batch documents and followed up with the
appropriate department to complete all pending activities prior to release of finished product via Inventory
Management Systems (SAP)
➢ Maintained FKC database for incoming products and communicated this information to other departments
➢ Documented, assessed and recommended corrective and preventative actions to resolve non-conformances such as
temperature deviation and out of specification results in Trackwise System
➢ Coordinated with Third Party Warehouses to forward product samples to testing laboratory and ensured retention
samples are stored properly
➢ Responsible for GMP and ISO audits for New Product Development and the release of batch records and maintaining
Reference Standards Program and coordinating sampling and testing of Returned Goods
➢ Reviewed freeze thaw and stability data, method transfer protocols and reports, validation protocols and reports and
provided quality support for product rework, product returns and product destruction
➢ Frequently provided training to colleagues and new employees on receiving, reviewing and releasing product
➢ Tracked Key Performance Indicators (KPI) regularly and provided my findings to management, with the goal of
driving decision making and changes to strategy
ARLA FOODS INC., Concord ON 2009 – 2010
Quality Assurance Technician
➢ Responsible for pre-operational and operational plant inspections and corrective actions as per CFIA and HACCAP
requirements
➢ Ensured that all pre-operational swabbing was completed for all packaging and production departments
➢ Managed all microbiological and compositional testing, performed on all products made in the plant, to ensure they
are safe for distribution and meet all compositional requirements

2. APOTEX Inc., Toronto
Document Reviewer, Formulations Development (FD) 2006 – 2009
➢ Reviewed batch documents including stability submission batches, protocols, technical reports and test results
generated for completeness and accuracy
➢ Created Quality Notification reports for deviations recorded during the review process
➢ Provided batch document updates for Clinical Trial Application (CTA) filings to scientists and other departments
➢ Guided and trained the FD & Technical Operations departments regarding the document review process
Document Reviewer, Quality Assurance In-Process (QAIP) 2003 – 2006
➢ Reviewed master production documents and master recipes for completeness and accuracy in accordance to GMP and
company standards
➢ Reported all deviations encountered during the document review process to the department supervisor and manager
through quality notification in SAP
➢ Ensured that the production/packaging process followed the established master formula
➢ Provided training to document reviewers ensuring that training records were accurate and completed
➢ Verified that the materials used in the supply chain have been appropriately reviewed and released
➢ Verified additional sampling/testing requirements as per Q-notification or validation protocol
In-Process Technician, Quality Assurance (QAIP) 2001 – 2003
➢ Coached and guided manufacturing personnel on following GMP requirements
➢ Conducted GMP manufacturing plant audits with respect to personnel, premises, equipment and documentation
➢ Ensured the timely completion of in-process checks, start-up approval and documentation review
➢ Conducted in-process testing for solid dosage: disintegration time, friability, hardness and weight variation
➢ Swabbed cleaning validation samples and liaised with the quality control lab to obtain results
➢ Executed micro sampling and macro sampling of in-process material as per protocols
➢ Maintained technical proficiency on GMP and provided guidance to all departments
EDUCATION AND TRAINING
SENECA COLLEGE, Toronto, Ontario 2003 – 2007
Advanced Pharmaceutical Formulation Methods, Qualification and Validation of Pharmaceutical Processes and Equipment,
Auditing and GMP Documentation, and Business Writing Skills
PHARMACEUTICAL SCIENCES GROUP (PSG), Toronto, Ontario
Microbial Limit and Bioburden Tests, Batch Record Review and Investigation, Conducting Investigation and Writing
Investigation Report, Investigation of Atypical and Out of Specification Laboratory Results, GMP Auditing, Fundamentals of
GMPs, Medical Device – Quality and Regulatory Requirement for Importer/Distributor and Manufactures, Leadership
TORONTO INSTITUTE OF PHARMACEUTICAL TECHNOLOGY, Toronto, Ontario 2000
Post-Graduate Diploma in Pharmaceutical Quality Assurance Technology
GUJARAT UNIVERSITY, India 1989
Master of Science Degree (M.Sc) in Microbiology (Equivalent to Bachelor of Science degree from University of Toronto)
PROFESSIONAL AFFILIATIONS
Health and Safety Committee Member 2009 – 2014
Completion of Certification program- Workplace Safety and Prevention
Completion of Standard First Aid with CPR A +AED
TOASTMASTERS, Toronto Ontario 2008 – 2014
Communication and Leadership Manual, Certificate of Merit
APOTEX INC. MENTORSHIP PROGRAM, Toronto Ontario 2008 – 2009
Mentor to three high school students expressing an interest in science