Qa Specialist
CurrentContinued with responsibilities in the role described prior to this one.Additionally, also a quality contact liaison for Bora working with GSK.
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Patsy Brooks is listed as QA Specialist at Bora Pharmaceuticals, a with 77 employees, based in Oakville, Ontario, Canada. AeroLeads shows a matched LinkedIn profile for Patsy Brooks.
Patsy Brooks previously worked as QA Specialist/ Regulatory Compliance at Glaxosmithkline and QC Supervisor, Stability Program and Analytical Review at Glaxosmithkline. Patsy Brooks holds Bsc, Chemistry, Microbiology, Biochem, Food Chem from Toronto Metropolitan University.
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Patsy Brooks is a QA Specialist at Bora Pharmaceuticals.
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Mississauga, Ontario, Canada
Continued with responsibilities in the role described prior to this one.Additionally, also a quality contact liaison for Bora working with GSK.
Mississauga, Ontario, Canada
Stability / Operational Quality Specialist/ Regulatory Compliance- Extremely organize and proactive, managed timelines extremely well.- Able to manage several projects simultaneously- Experience in Change Control, Regulatory Compliance; Batch Review and Release; PPRs; Deviations, Complaints.- Write/Review/approve documents including SOPs, stability protocols/reports, PBRs, BOMs, CDisy, eBRS, Freeweigh, etc.- Prepared/ contributed to US FDA Annual changes reports.- contributed to preparations and reviews of EU/ROW/Intl’l / Japan submission dossiers/ conformance guides working with international teams using electronic submission database.- Participated in internal and external audits as a subject matter expert.- Worked on several Process improvements projects.
Mississauga, Ontario, Canada
Stabililty Program Management and Analytical Review of Finished Products, Stability Studies and Raw Materials- Write/Review/approve documents including SOPs, stability protocols/reports, etc.- Supervise QC Review and Release Team.- Supervise and manage the Retain/Reserve sample inventory program.- Supervised/Coordinate management of the Commercial Ongoing Stability Program in accordance with registered details, GMPs, ICH and FDA guidelines.- experience with Interview and selection of hires; conduct performance reviews.- Prepare/ contribute to US FDA Annual Stability reports using electronic submission database.- Participates in internal and external audits as a subject matter expert.- Work on several Process improvements projects.
Mississauga, Ontario, Canada
Progressed from Analyst, testing material and finished goods to coordinating Lab activities.Supervised the Raw Material Lab.
Other employees you can reach at boracorpcdmo.com. View company contacts for 77 employees →
James Vernon
Colleague at Bora PharmaceuticalsHamilton, Ontario, Canada
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Sara Miller
Colleague at Bora PharmaceuticalsAberdeen, Maryland, United States
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Vedant Modgill
Colleague at Bora PharmaceuticalsHamilton, Ontario, Canada
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Nikolay Georgiev
Colleague at Bora PharmaceuticalsMays Chapel, Maryland, United States
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Cicala Lin
Colleague at Bora PharmaceuticalsLuzhou District, New Taipei City, Taiwan, Province Of China
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Marie Luz Molina Batista
Colleague at Bora PharmaceuticalsBaltimore, Maryland, United States
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Pauline Clarke-Domes
Colleague at Bora PharmaceuticalsOntario, Canada
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Nancy Bhela
Colleague at Bora PharmaceuticalsUnited States
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Mariam Farag, Pmp, Eit
Colleague at Bora PharmaceuticalsMississauga, Ontario, Canada
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Mars - Yi Cheng H.
Colleague at Bora PharmaceuticalsHsinchu County, Taiwan, Province Of China
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Patsy Brooks works for Bora Pharmaceuticals.
Patsy Brooks is listed as QA Specialist at Bora Pharmaceuticals.
Patsy Brooks is based in Oakville, Ontario, Canada while working with Bora Pharmaceuticals.
Patsy Brooks has worked for Bora Pharmaceuticals and Glaxosmithkline.
Patsy Brooks's colleagues at Bora Pharmaceuticals include James Vernon, Sara Miller, Vedant Modgill, Nikolay Georgiev, and Cicala Lin.
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Patsy Brooks holds Bsc, Chemistry, Microbiology, Biochem, Food Chem from Toronto Metropolitan University.
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