Anton Birman
Newmarket,Canada
Summary
A highly motivated and enthusiastic individual with extensive Quality Control and Quality Assurance experience within the chemical/pharmaceutical industry, including several years in a managerial role. Excellent time-keeping skills, proven problem-solving and analytical thinking result in effective solutions. Ability to lead and inspire teams whilst encouraging individual development. Strong computer literacy including Word/Excel/SharePoint. Knowledge of various QMS computerized systems (TrackWise, LIMs, etc...). Experience in leading and conducting Audits/inspections and hosting regulatory inspections. Knowledge in following regulations FDA, Health Canada, PIC/s, ISO 13485, and more.
Overview
16
16
years of professional experience
Work History
Quality Systems Manager
Baxter International Inc
03.2021 - Current
- Part of the Senior Leadership Team ( SLT), responsible for ensuring the implementation of an effective Quality System for the Alliston site pharmaceutical operations by compliance with applicable regulations, alignment to Baxter global processes/ procedures, managing a group of Quality professionals responsible for Quality System elements on a day to day basis, influencing and collaborating with others to pursue Right First Time
- Taking decisions based on data and inputs from Subject Matter Experts, applying Risk Management principles, and escalating significant quality issues to the Quality Management Representative (QMR) in a timely fashion
- Acting as QMR designee
- Major responsibilities include: Implementation of key Quality System Elements, Oversight of the Alliston Quality System considering Risk Management principles, Product Quality Escalations and Field Action site representative, Assisting the QMR by coordinating and monitoring activities related to the site Quality Plan, working in partnership with all site functions, Scheduling and coordinating Quality Management Reviews, Scheduling and coordinating the internal audit program and customer audits, Establish and manage an Inspection Readiness process, including identification of Subject Matter Experts by topic, Back Room and Inspection Room, monitoring of work before and after inspections/ audits to support that the site is consistently Inspection Ready, Ensuring new/ revised SOPs, NCRs, Change Controls, APQRs, and other GMP processes/ procedures are developed, reviewed and approved with the required rigor, considering interfaces throughout elements (e.g., Documentation & Training; Change Controls), Ensure Change Control/Product Control Specifications related to Label changes are managed, controlled and implemented, Leading the site NCR/ CAPA Review Board, Leading Supplier Quality on-site, Responsible for coordinating and deploying training/coaching to site personnel on Trackwise (for NCRs, Complaint Handling System), Manages the Scheduling, coordinating, and leading of site Quality Key Process Indicators (KPIs) data compilation, analysis, identification, and follow-through of actions for various Quality forums or site meetings with Quality agenda topics, Review and provide QA approval of procedures, Out of Limit investigations, Trending Reports, and other GMP documents corresponding to the Quality Control Laboratories, Managing personnel; including allocating work, and driving performance actions such as recognition, and performance development, Acting as QMR designee.
Quality Specialist II
Baxter International Inc
07.2019 - 03.2021
- Quality Specialist covering most of the Quality Systems areas such as Complaints, Quality approver for NCR, CAPA, Change Control, Documentation management, and Lab
- Investigations, Field Action site representative, and Plant Risk management
- As part of the Inspection readiness team, assist in collecting all relevant documentation, coordinate SMEs, and combine observation responses in case required
- Lead for Quality in the QC Labs and oversee all QC activities from a quality assurance perspective
- Reporting directly to site QMR, assisting with plant-related tasks/activities.
Senior Quality Assurance Reviewer and Investigator
SGS Canada Inc.
07.2016 - 07.2019
- Assure that QC records are compliant with methods, protocols, specifications, and the company's SOPs
- Identify and lead the improvement of SOPs, analytical methods, protocols, and forms
- Provide industry quality and regulatory guidance on non-routine matters, ensure records of Validation/Method Transfer/Verification and reports are as per protocol
- Assure that OOS investigations are performed according to local SOPs
- Consults QC Investigator and review OOS investigations according to local SOPs and regulatory requirements
- Input data for trending of departmental KPls
- Identify, support, and often lead operational improvement initiatives while facilitating stakeholder negotiation and alignment
- Participate in regulatory and client audits as process owner and/or SME.
Quality Control Supervisor
Teva Pharmaceuticals LTD.
04.2014 - 05.2016
- Supervisor of a team of 11 analysts in Product dedicated cluster
- Team performing analysis of Raw material to final product including in process Control testing
- Perform work scheduling and troubleshooting, leading the team to performance excellence and release of the product in a timely manner
- Leading OOS/Lab
- Related investigations to closure, performing root cause analysis and initiating/closing CAPAs using different tools such as 6 Sigma/fishbone analysis/ 5 whys, etc
- Working with different departments ( Production facilities, R&D, QA), performing employee SOP/GMP training and performance evaluation
- Conducting cross-QC team internal audits and assisting with identifying the root cause and correction of the observations.
Analytical Chemist
Teva Pharmaceuticals LTD.
07.2010 - 03.2014
- Conduct quality control tests
- Open OOS/LIR Investigation if required
- Document the test outcome in a timely manner and as per local SOPs and GMP requirements
- Review documentation of other employees and make corrections if required
- Work with a wide variety of QC instrumentation such as HPLC, GC, IC, UV, IR, KF, and more.
Process Engineer
Teva Pharmaceuticals LTD.
05.2008 - 02.2009
- Process Engineer at an organic waste treatment facility
- Project to improve facility yield and environmental condition (airflow, bacteria efficiency, etc.
Education
Bachelor of Science - Chemical Engineering
SCE College of Engineering
08.2009
Practical Engineer - Diploma - Mechanical Engineering
Harmelin College of Engineering
06.2001
Skills
- Project Management
- Team Management
- Quality Control
- Quality Assurance
- Root Cause Analysis
- Continuous Improvement
- Documentation Control
- SOP Development
- Team Training
- Audit/Host inspections
- Internal Quality Audits
- Risk Mitigation
Languages
English
Full Professional
Russian
Full Professional
Hebrew
Native or Bilingual
Timeline
Quality Systems Manager
Baxter International Inc
03.2021 - Current
Quality Specialist II
Baxter International Inc
07.2019 - 03.2021
Senior Quality Assurance Reviewer and Investigator
SGS Canada Inc.
07.2016 - 07.2019
Quality Control Supervisor
Teva Pharmaceuticals LTD.
04.2014 - 05.2016
Analytical Chemist
Teva Pharmaceuticals LTD.
07.2010 - 03.2014
Process Engineer
Teva Pharmaceuticals LTD.
05.2008 - 02.2009
Bachelor of Science - Chemical Engineering
SCE College of Engineering
Practical Engineer - Diploma - Mechanical Engineering
Harmelin College of Engineering
Similar Profiles
SANDRA FASTSANDRA FAST
Customer Support Tech II at BAXTER INTERNATIONAL INCCustomer Support Tech II at BAXTER INTERNATIONAL INC
Scott HardgraveScott Hardgrave
Senior Software Engineer at Baxter International IncSenior Software Engineer at Baxter International Inc
Milivoje DimitrijevicMilivoje Dimitrijevic
Clinical Sales Specialist at Baxter International IncClinical Sales Specialist at Baxter International Inc
Manuel DiazManuel Diaz
Evaluation Technician at Baxter International IncEvaluation Technician at Baxter International Inc
Shaylee GhaffariShaylee Ghaffari
Cashier at Canadian TireCashier at Canadian Tire