T: (905) 363-1182 x215
TF: 1 (877) 877-5152 x215
2550 Argentia Road, Suite 119, Mississauga, ON L5N 5R1
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Kruti Dhyani, Lead Consultant
Kruti Dhyani is an experienced Quality Assurance professional with 7 years of experience. Kruti has a strong background knowledge in Health Canada, FDA and ICH regulations. Kruti has experience with Annual Product Reviews, including the review of complaint investigations, deviations, change controls, product summaries and process attributes. Kruti’s professional and educational background add to the depth of the Q&C team.
Skills & Highlights
- Reviewed and approved Annual Product Quality Reviews (APQRs) to ensure that the analysis of manufacturing and packaging process, critical in-process attributes, the validation status, regulatory status, stability status, APIs and excipients manufacturer status of the product are accurate.
- Dispositioned raw material batches, intermediates, and finished products by verifying, reviewing and ensuring compliance with the marketing authorization and manufacturing requirements such document review completion, stability requirements, process validation, analytical testing, sample deduction, and regulatory approval.
- Performed inventory SAP transactional activity to support quality investigation, movement of material, inter-warehouse transfer of product.
- Initiated and investigated quality compliants, coordinated sample return, prepared response letters.
- Initiated change control records, identified change assessors as well as pre/post implementation action items. Provided impact assessment on deviations impacting Annual Product Review system.
- Assisted in performing SDC impact analysis for API.
- Investigated and managed closure of deviation investigations and CAPAs.
- Assisted in managing quality agreements with suppliers.
- Performed verification of Container Closure System.
- Reviewed process validation protocols and reports.
- Performed internal audits.
- Assisted in preparation of Health Canada GMP and ISO audits.
- Assisted in achieving quality management system compliance with ISO 13485:2003.
- Developed a dental unit waterline cleaner submission in compliance with FIFRA regulation.
- Prepared, coordinated and supervised regulatory submissions in compliance with EPA.
- Prepared and maintained renewals of established registrations, device listing and licences.
- Managed the development, review, approval and tracking of labels.
- Prepared and submitted change-notifications and amendments to support post approval changes.
- Responded to clarifications from Regulatory authorities.
Quality Control (QCO)
- Experience with water testing: waterline, spore, microbial contamination tests.
- Conducted product stability testing.
- Experience with testing of raw materials used in manufacturing.
- Performed in-process and final product testing using HPLC, UV and IR.
- Developed, revised and implemented Work Instructions, forms and Standard Operating Documents.
- Reviewed and approved Master Manufacturing and Packaging documents.
- Prepared certification document templates such as Certificate of Manufacturing, Certificate of Manufacturer’s Declaration.
- Developed an annual GMP training course
- Provided GMP and safety trainings
- Executed QMS software trainings
Awards, Recognition and Achievements
- P.A.I.D. for Excellence
- Project Management Certification, Can-Consult Institute, Mississauga, ON
- Post Graduate Certification, Pharmaceutical Regulatory Affairs and Quality Operations, Seneca College, Toronto, ON
- Bachelor of Science, Biology, York University, Toronto, ON
- Advanced Diploma, Biotechnology Technologist Research, Seneca College, Toronto, ON
- Diploma, Chemical Laboratory Technician, Seneca College, Toronto, ON
Continuing Education, Career Development
- Lead Investigator/ QA Approver Certification
- Qualified Trainer
- Managing GMP Regulations
- Quality Risk Management
- Technical Writing
- Change Control Initiator and Approver
- Problem Solving Tools and Techniques
- Customer Complaints Initiator and Approver
- High Impact Business Writing