Blaire Lam-Greene
North York,ON
Overview
10
10
years of professional experience
Work History
Senior Technical Manager
Hoffmann La Roche
03.2020 - Current
Technical Manager
Hoffmann La Roche
03.2019 - 03.2020
- Deliver APQR reports for Roche commercial products per GSP037, and propose actions items as required
- Contribute to performance metrics and overall quality assessment and reporting as part of the APQR business process
- Identify, escalate and resolve complex issues related to global processes
- Provide training and guidance as needed regarding the Global APQR process, including planning and the implementation of procedures
- Identify and communicate process and/or product quality issues in a timely manner, including recommendations for resolution and/or the determination and implementation of new methods
- Monitor global APQR metrics and apply Lean Production System principles to continuously improve the APQR process
- Ensure cross-functional team deliverables are completed in a compliant, accurate, high quality and timely manner
- Leverage matrix leadership to coordinate activities of varying complexity which are needed to meet team objectives and support the APQR business process across the Roche network
- Act as SSF Quality Approver for production discrepancies
- Team member for Roche as a Legal Manufacturer on the Post-Market Surveillance stream
- SSF and Basel APQR Site Lead
- Co-created Roche FutureWorks, an early talent development pipeline
Quality Compliance Associate
Pfizer Consumer Healthcare
01.2017 - 03.2019
- Participate in product launches as the quality representative
- Manage and execute tasks related to review of Annual Product Reviews and Product Stability Reports
- Manage and execute all tasks related to the creation, review and closure of Site Change Controls in conjunction with the Quality Assurance Manager
- Develop relationships within other affiliate departments, other Pfizer sites and selected non Pfizer sites
- Execute tasks related to the creation, review and closure of reportable events and investigations
- Create and revise local Standard Operating Procedures and Work Instructions
- Assist with the audits of the local third party contract vendors
- Performs local release of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale
- Act as strategic partner to internal stakeholders on prioritization for lot release
- Review and approval of artwork
- Reporting on metrics for various quality systems
- Communicate the changes, as required to key global Quality contacts
- Maintain inspection readiness and actively participate in the self-inspection program
- Participates in the preparation of Regulatory Agency and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities at the PCO
- Assists in tracking the implementation of the identified actions within agreed timeframes
- Participates in ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.
Quality/Regulatory Account Manager
Q&R Canada Inc.
01.2015 - 01.2017
- Ensure complaints are investigated, follow-up actions are implemented and their effectiveness assessed, generate annual complaint trending reports
- Review and determine the status of clients GMP Documents
- Initiate and conduct Deviations, Out-of-Specification, Corrective Action and Preventative Action (CAPA), and Change Control Procedures
- Lead the reporting of adverse events, drug reactions, and recalls
- Support audits and inspections
- Draft and revise Standard Operating Procedures (SOPs)
- Liaise with clients to create business strategies for product launch
- Liaise with Health Canada to ensure regulatory and quality compliance
- Maintain the current Licences and foreign site information
- Maintain current DINs and NHPs
- Submit Medical Device Submissions
- Manage sample testing schedules
- Liaise with product suppliers
- Training new staff
Regulatory Affairs & Quality Assurance Associate
Experchem Laboratories
01.2014 - 01.2015
- Assist with self-inspections and HPFBI audits
- Draft and revise Standard Operating Procedures (SOPs), Annual Safety Summary Reports, and Annual Quality Product Reports
- Draft letters to clients and/or regulatory authorities as required
- Initiate and conduct Deviations, Out-of-Specification, Corrective Action and Preventative Action (CAPA), and Change Control Procedures
- Generate Finished Product and Stability Specifications
- Assess the disposition of damaged and returned goods
- Review and correct warehouse and shipping documents
- Review and draft APQRs
- Review and determine the status of clients GMP Documents
- Training new staff
Education
Graduate Certificate - Pharmaceutical Regulatory Affairs and Quality Operations
Seneca College of Applied Arts and Technology
01.2014
Honours Bachelor of Science - NeuroscienceEcology & Evolutionary Biology
University of Toronto - St. George Campus
01.2012
Skills
- Effective and diplomatic communicative abilities to work with cross-functional teams and external stakeholders with strong negotiation skills
- Quick leaner, excels in fast paced environments
- Self-motivated to work highly independently, but great a great collaborator
- Strong ability to collect and interpret complex data, and generate thoughtful, organized reports and presentations
- Great project management abilities and business acumen
Research
- Partnership between University of Toronto & The Ontario Health Coalition, 2012, City of Toronto proposed divestment of public long-term care homes affecting more than 2,000 residents: new report
- Neotropical Field Course, University of Toronto, 2011, Bait recruitment efficiencies: the effect of ant size and bait discovery in a neotropical forest
Timeline
Senior Technical Manager
Hoffmann La Roche
03.2020 - Current
Technical Manager
Hoffmann La Roche
03.2019 - 03.2020
Quality Compliance Associate
Pfizer Consumer Healthcare
01.2017 - 03.2019
Quality/Regulatory Account Manager
Q&R Canada Inc.
01.2015 - 01.2017
Regulatory Affairs & Quality Assurance Associate
Experchem Laboratories
01.2014 - 01.2015
Graduate Certificate - Pharmaceutical Regulatory Affairs and Quality Operations
Seneca College of Applied Arts and Technology
Honours Bachelor of Science - NeuroscienceEcology & Evolutionary Biology
University of Toronto - St. George Campus
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