Elena Chirca Email & Phone Number

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Business Services Consulting: Working closely with clients to identify product improvement opportunities, define realistic goals aligned with the strategic roadmapPractice methodology: Implement, adapt and scale-up Scrum with Kanban frameworkTeam organization: Leading and coaching the delivery team of 7 members

Montreal, Quebec, Canada

Manage cross-functional subject matter experts to design, test and implement PLM - Product Life-Cycle Management SystemPerform change management and process improvement of product development critical steps in order to gain efficacy, reduce workload and avoid overlapsAdapt and apply various project management methodologies, including Agile Scrum and Kanban

Montreal, Canada Area

Coach and develop a dedicated quality assurance teamLead digitalization quality projects: Implement LIMS product specifications, testing and quality control, integrate with JD Edwards ERP inventory and batch releases. Computer validation and CFR21 part 11 complianceLead GMP FDA and Health Canada compliance audits for manufacturing and testing of.

Montreal, Canada Area

Manage the quality system of Canadian and US subsidiaries: market product releases, approval of internal procedures, quality manuals, quality agreements, change management, CAPA and complaints, stability and validation programPrimary contact with Health Canada and FDA regarding the regulatory compliance and GMP audits

Brossard, Canada

Propose, write and implement new procedures and work instructions to improve GMP compliance and operational flowAct as quality subject matter expert (SME) for the Microsoft Dynamics ERP implementation - process mapping, databases

St-Laurent

Perform analyses and complex preparation of water samplesInterpret analytical results and write analytical reports

Longueuil, Canada

Bucharest, Romania