Jennifer Roach
Sr Quality Solutions Lead, Global Product Development Quality at Roche
Based in Burlington, Canada
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Seniority
Other
Department
Other
Location
Burlington
Industry
Biotechnology Research
Company size
104K
Contact information
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j•••••••@roche.com
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Background
About Jennifer Roach
Senior Pharmaceutical Quality Assurance Manager with background in Regulatory Affairs • Detail oriented with over 20 years of pharmaceutical industry experience in Quality Operations/Systems and Regulatory Affairs Quality Operations/Systems: • Management of Complaint handling system and complaint product trending • Management of Third Party manufacturers • Maintenance, review and approval of master documentation • Review and approval of deviations including root cause analysis • Product release • Annual product reviews • Product recall duties • Preparation of Quality Agreements • Assist in and prepare for Regulatory and Customer audits • Review and approval of Change Controls • GMP Trainer Regulatory Affairs Operations: • Compilation and submission of eCTD dossiers to worldwide jurisdictions • Product life cycle management • Provincial formulary submissions • Compilation and submission of eCTD dossiers to worldwide jurisdictions • Product life cycle management • Provincial formulary submissions • Labelling related activities • Product launch responsibilities
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