INNA VAISBROT
Vaughan,Canada
Summary
Highly motivated and committed pharmaceutical professional with strong experience and technical knowledge in GCP, MDR/IVDR, SaMDs, GVP, RBQM, Risk Management, and QMS. Skilled in leading large projects within a matrix environment, facilitating decision making and communication, while possessing strong digital and data literacy. Demonstrated success in project management from initiation to timely and successful product launches through close collaboration with business, R&D, manufacturing, QA, and other functions. Recognized for driving project completion, eliminating backlogs, implementing efficient project tracking systems, and streamlining processes to ensure compliance. Expertise in Root Cause Analysis Tools as detailed in ICH Q9 (R1) Annex I: Fish bone (Ishikawa diagram), 6M's, 5 Why's, FMEA, FTA, HACCP. Extensive experience in Annual Product Reports and Quality agreements as outlined in FDA guidance for Industry and ISO13485. Excellent knowledge of data management and documentation practices (ALCOA+) that ensure the accuracy, reliability, and completeness of data generated for drug development, regulatory submissions, and post-market monitoring. In-depth understanding of regulatory requirements and health and safety standards including Food and Drug Act and Regulations, GxP, USP, ICH, Ontario Occupational and Safety Act.
Overview
10
10
years of professional experience
Work History
Project Leader, R&D QA GQC-CMC
Apotex, Global Health company
01.2022 - Current
- Lead Quality Improvement Projects to ensure the quality and regulatory compliance of pharmaceutical products by setting up robust quality systems and overseeing their implementation
- Collaborated with a team of experts and peers across the organization to identify, design, and deliver quality solutions
- Facilitated teams to discuss, address, and resolve issues related to safety, quality and other relevant subjects
- Monitored and reported project progress at regular intervals to key stakeholders (on site) and clients
- Lead cross -functional project teams to ensure project deliverables and timelines are met
- Supported decision-making on projects and future directions by trending deviations in Track Wise (TW)
- Performed risk assessments for the changes triggered by the project related activities
- Established a metric system to evaluate gained improvement
- Developed and successfully implemented Compliance Monitoring and Improvement Program (CMIP), Investigations Streamlining project
- Executed required Quality activities to support product launches, including vendor qualification, quality agreements, stability data, validation data, and technology transfer data review
R&D QA Senior Associate, GQC-CMC
Apotex
01.2020 - 01.2022
- Provided leadership and support through standardization and streamlining of processes, improve support mechanisms and activities in accordance with applicable regulations
- Performed a final overall quality review of regulatory submission documents to ensure the science/data/conclusions are sound, comply with regulatory standards, and ensure that submissions are of high quality, consistent and complete
- Performed a concurrent review of critical submission documents (e.g Batch Records, validation/stability reports, Specifications/CofA/Release Results, technical reports/summaries) for accuracy, completeness, compliance, appropriate content/justifications, adherence to regulatory guidelines, strategies, and commitments
- Dispositioned non-commercial batches such as Investigational Medicinal Products in support of regulatory filings
- Reviewed and approved deviation investigations in QMS TrackWise to ensure investigation completeness, root cause determination, CAPAs design and implementation, and effectiveness check design and justification
- Participated in hosting regulatory and customer audits, prepared audit observation responses and CAPAs
- Carried out trend evaluation using historical data for comparison and initiated action plans when required
- Provided leadership and mentoring to junior associates and represented R&D Quality in cross functional meetings
- Acted as delegate for manager as required
Senior Documentation Specialist, Team Leader
Dalton Pharma Services
08.2019 - 01.2020
- Coordinated and supervised the activities of the Production Documentation Group consisting of documents reviewer(s) and technical transfer specialist(s)
- Reviewed executed production documents to ensure that all steps have been performed as per approved procedure and documented as per GDP requirements
- Initiated investigations for any deviations observed during the production document review
- Delegated investigation to the involved department(s) to open a Deviation report
- Ensured that the deviation report includes an investigational plan, determination of root cause, impact assessment, and corrective actions plan
- Coordinated interdepartmental (Production, QC, Stability, Materials etc.) review of production documentation to ensure synchronization of instructions
- Liaised with departments involved in the manufacturing process to capture all relevant information, e.g
- Production, Chemistry, Materials, Facilities, QC, Microbiology, Stability, Calibration, and Validation
- Participated in customer complaints investigation activities
- Provided training on new Good Documentation Practice and GMP / SOPs updates
- Tracked production documentations, change controls, deviations and CAPA to ensure timely completion
- Supported QA management in hosting regulatory and customer audits, prepared audit observation responses and CAPAs
QA Documentation Specialist
Dalton Pharma Services
08.2016 - 08.2019
- Reviewed Analytical tests ( HPLC, GC, ICP, DSC, TOC, Dissolution, Karl Fisher etc.) for raw materials, in-process products, final products and Stability samples as per approved SOPs
- Ensured that all observations have been corrected
- Informed Analyst’s Supervisor in case of any deviation from the approved procedure has been discovered to initiate a Deviation Report
- Prepared Stability trends and initiated investigations for Out Of Trends (OOT) results
- Performed Method Validation/Method transfer review
- Assured records of Method Validation/Transfer and reports comply with protocol and method provided by clients
- Reviewed instrument qualification data
- Performed Facility Infrastructure review
- Initiated, controlled, and approved investigation for any deviation observed to evaluate product or process impact
- Coordinated with technical and production staff for developing corrective action plan CAPA
- Provided information on latest standards, specifications, procedures and requirements related to existing and new products
- Developed Specification for new and existing products
- Assisted in conducting root cause analysis for customer complaints and internal quality issues
- Participated in processes/equipment validation
- Participated in FDA and Health Canada audits
Education
Quality Assurance/Quality Control Post Graduate Diploma -
Toronto Institute of Pharmaceutical Technology
01.2012
Microbiology Post Graduate Program - undefined
Michener Institute for Applied Health Science
01.2011
Bachelor of Science Degree - Analytical Chemistry
University of Toronto
01.2008
Skills
- Problem-solving abilities
- Critical thinking
- Strategic thinking
- Effective communication
- Adaptability and flexibility
- Decision-making
- Detail-oriented
- Creative thinking
Languages
English
Native or Bilingual
Timeline
Project Leader, R&D QA GQC-CMC
Apotex, Global Health company
01.2022 - Current
R&D QA Senior Associate, GQC-CMC
Apotex
01.2020 - 01.2022
Senior Documentation Specialist, Team Leader
Dalton Pharma Services
08.2019 - 01.2020
QA Documentation Specialist
Dalton Pharma Services
08.2016 - 08.2019
Microbiology Post Graduate Program - undefined
Michener Institute for Applied Health Science
Bachelor of Science Degree - Analytical Chemistry
University of Toronto
Quality Assurance/Quality Control Post Graduate Diploma -
Toronto Institute of Pharmaceutical Technology
Similar Profiles
Nashid KarimNashid Karim
Project Leader at Global Pharmacovigilance Quality and Collaboration, Apotex IncProject Leader at Global Pharmacovigilance Quality and Collaboration, Apotex Inc
Simarjeet DhaliwalSimarjeet Dhaliwal
Office Administrator at Apotex Pharmaceutical CompanyOffice Administrator at Apotex Pharmaceutical Company
Sreedas PSreedas P
Senior Manager –Service Delivery ( Azure & M 365 – India , Middle East & APAC Region) at Kryptos Technologies PVT LTD ( A Crayon Global Company): Global Microsoft Partner for Azure & M365Senior Manager –Service Delivery ( Azure & M 365 – India , Middle East & APAC Region) at Kryptos Technologies PVT LTD ( A Crayon Global Company): Global Microsoft Partner for Azure & M365
Iboro-obong EkefreIboro-obong Ekefre
Senior Human Resources Generalist at Digital Shovel Holdings Inc.Senior Human Resources Generalist at Digital Shovel Holdings Inc.
Matan ZamirMatan Zamir
Camp Counselor at City of VaughanCamp Counselor at City of Vaughan