LODAI NATEMO
Mississauga,Canada
Summary
Results-driven Quality and Regulatory Affairs Supervisor at Sante Manufacturing Inc. with expertise in regulatory submissions to Health Canada and the FDA. Proven track record in leading GMP audits and implementing quality systems, ensuring continuous compliance and readiness for inspections. Strong attention to detail and effective communication skills have consistently contributed to organizational success in meeting regulatory standards.
Overview
9
9
years of professional experience
Work History
Quality and Regulatory Affairs Supervisor
Sante Manufacturing Inc.
Aylmer, Ontario
05.2021 - Current
- Leading deviations and customer complaint investigations
- Participating in third-party GMP/cGMP audits and regulatory inspections
- Tracking and trending KPIs
- Carrying out regulatory submissions for the company with Health Canada and FDA
- Advising the company on new regulatory changes that require implementation
- Ensuring that the company is always GMP compliant and in a state of audit-readiness
- Reviewing and approving the company's SOPs, quality documents and protocols
- Approving the company's suppliers and contractors
- Reviewing quality contract agreements
- Designed and oversaw successful implementation of the company's quality system
- Successfully hosted Health Canada and third-party GMP audits between 2021 and 2022
QA Associate
PCI Pharma Services
Mississauga, Ontario
08.2020 - 05.2021
- Company Overview: PCI Pharma Services is a third-party pharmaceutical packaging organization whose goal is to bridge the gap between the pharmaceutical/Biopharmaceutical companies and patients through provision of primary and secondary packaging services for clinical and commercial products
- Reviewed executed batch documents and made release/rejection dispositions
- Logged initiated Change Control/Change Management for packaging processes, primary packaging components and suppliers/vendors in the company's Change Control database
- Investigated deviations and customer complaints
- Collaborated with customers' Quality Assurance teams in projects/investigations related to their products at PCI
- Reviewed and approved protocols and other internal documents
- Initiated planned deviations for temporary changes in packaging processes and/or packaging components
- Participated in qualification of PCI's suppliers
- Cross-functionally worked with the Production, Engineering and Maintenance departments in identifying Continuous Improvement (CI) areas
- Tracked and trended KPIs (Key Performance Indices) for quality metrics like deviations, complaints and RFT (Right the First Time) documentations
- Maintained a state of inspection readiness by ensuring that all investigations and CAPAs were closed within specified timeframes
- Reviewed SOPs related to QA and Production functions at PCI, as assigned by the Quality Director
- Initiated customer complaint investigations on ZenQMS (PCI's Quality Management Software)
- Released finished products on TROPOS (An ERP based system for managing inventory)
- PCI Pharma Services is a third-party pharmaceutical packaging organization whose goal is to bridge the gap between the pharmaceutical/Biopharmaceutical companies and patients through provision of primary and secondary packaging services for clinical and commercial products
QA Inspector
PCI Pharma Services (Formerly, Bellwyck Pharma Services)
Mississauga, Ontario
12.2017 - 08.2020
- Daily inspection of packaging areas to ascertain GMP compliance
- Reviewed packaging rooms logbooks, equipment logbooks and differential pressure logbooks
- Assisted in investigations and resolution of quality issues on the production floor
- Occasionally wrote deviations and complaint reports for non-conformances in the production floor
- Escalated quality issues to operations and quality management through Internal Occurrence Report Forms (IORFs)
- Educated packaging operators on GMP and monitored GMP compliance during packaging operations
QA Auditor (contract role)
Catalent Pharma Solutions
Windsor, Ontario
08.2016 - 10.2017
- Company Overview: Catalent Pharma Solutions is a CMO whose clients comprise some of the top Pharmaceutical and Biotechnology companies in the life science industry
- Conducted the review of batch documents and released product upon completion of the auditing/review process
- Filed and archived executed batch documents
- Assisted the QA Associates with the investigations of Non-conformances and writing of Non-conformance Reports (NCRs)
- Collected information related to quality issues during production
- Assisted in adherence to QA policies and procedures
- Catalent Pharma Solutions is a CMO whose clients comprise some of the top Pharmaceutical and Biotechnology companies in the life science industry
Education
B.Sc. - Biochemistry
University of Windsor
01.2016
Skills
- Experience in regulatory submissions to Health Canada and the FDA
- Technical writing
- Strong Attention to Detail
- Working knowledge of cGMPs/GMPs and ICH quality guidelines
- Working knowledge of computer software, like SAP and Trackwise
- Working knowledge of Microsoft Office (Excel, PowerPoint, Word, and Outlook)
- Interpersonal and collaborative skills
- Effective communicator in the English language (both verbal and written)
- Multitasking
- Continuous improvement
- Time management abilities
- Excellent communication
Knowledge And Skills
- Experience in regulatory submissions to Health Canada and FDA.
- Technical writing.
- Attentiveness to details.
- Working knowledge of cGMPs/GMPs and ICH quality guidelines.
- Working knowledge of computer software like SAP and Trackwise.
- Working knowledge of Microsoft Office (Excel, PowerPoint, Word, and Outlook).
- Interpersonal and collaborative skills.
- Effective communicator in the English language (both verbal and written).
References
References available upon request.
Timeline
Quality and Regulatory Affairs Supervisor
Sante Manufacturing Inc.
05.2021 - Current
QA Associate
PCI Pharma Services
08.2020 - 05.2021
QA Inspector
PCI Pharma Services (Formerly, Bellwyck Pharma Services)
12.2017 - 08.2020
QA Auditor (contract role)
Catalent Pharma Solutions
08.2016 - 10.2017
B.Sc. - Biochemistry
University of Windsor
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