Rosa Stroy Email & Phone Number

Winnipeg, Manitoba, Canada

Winnipeg, Manitoba, Canada

Responsible for the creation and maintenance of raw material, bulk, finished product and printed and non-printed packaging specificationsDetermines certificate of analysis requirements needed to ensure materials meet physical, chemical, and contaminant requirementsWorks in close collaboration with key stakeholders to conduct material assessments as part of the specification development processProvides Quality oversight over the material qualification process, reviews vendor documentation, and drafts specifications Ensures specifications are current with all applicable regulations and pharmacopoeiasEvaluates proposed changes in CCRs and assesses potential impact to specificationsSupports regulatory filings in relation to specification creation Updates SOPs and associated annexes as needed.Assigns tasks and delegates responsibilities to direct reportees. Oversees personnel in completing tasks and projects to scheduleProvides coaching, mentoring, constructive feedback and empowers direct repotees. Helps direct reportees resolve work related issues and disputes Communicates to direct reportees in an open, balanced and objective mannerSets performance goals and developmental plans for each direct reportee Participates in the recruitment of qualified staff for the department, trains new hires. Provides on-going training to department staff

Winnipeg, Manitoba, Canada

Led, conducted, and provided support for quality investigations. Worked in collaboration with Subject Matter Experts of various departments to identify root cause(s) and implement appropriate corrective and/or preventive actions. Determined effectiveness of corrective and/or preventive actionsInterfaced closely with cross-functional groups such as Manufacturing, Packaging, Maintenance, Product and Process Development and Warehousing. Coordinated cross functional meetings and reported findings to managementConducted risk assessments following established risk procedures to identify areas for improvementAssisted in investigations with vendors or Supplier Development and Procurement Management for issues associated with raw materials, contract manufacturing and componentsProvided training on investigative processes and root cause analysis tools to functional areasParticipated in cross-functional teams on process control, continuous improvement, and optimization projects. Recommended quality process improvements to increase efficiencies and performance of systems, operations, and personnel to prevent reoccurrence of incident or eventsParticipated in and supported the maintenance of the Quality Management System through involvement with deviations, investigations, out of specification (OOS), and corrective action preventative action (CAPA) systemsReviewed master production, Quality Control and Quality Assurance change control documentation approvals. Reviewed standard operating procedures, methods, and specification approvals

Winnipeg, Manitoba, Canada

Performed Batch Record Review including raw materials, bulk products, and Quality Control testing records. Ensured that records meet GMP requirements for Good Documentation Practices Reviewed and followed up on all batch related deviations. Ensured all deviation reports are adequately resolvedCoordinated release documentation (Certificate of Packaging and Certificate of Manufacturing) with customersInitiated Change Controls and Deviations as requiredUpdated and created Standard Operating Procedures to align with current practicesMonitored GMP compliance in the facilityLiaised with other departments on QA related issuesParticipated in Regulatory audits

Provided regular, timely, and relevant feedback for Quality Assurance industry level activities andassignmentsAssessed student generated recalls, from initiation, execution to closureAnalyzed student generated prerequisite program and HACCP PlansEvaluated student generated validation protocols and reportsReviewed microbiological lab reportsAssisted in monitoring students during internal audit of RRC pilot manufacturing plants.Evaluated student generated internal audit observations and reportsAssisted in the preparation of marking rubrics/criteriaParticipated in other program support tasks as assigned

Developed, implemented, maintained, and reviewed a HACCP PlanReviewed all Critical Control Point (CCP) monitoring and verification records to ensure compliance with HACCP critical limits and frequenciesValidated changes to the Food Safety PlanLed internal audits, customer audits, and third-party audits, prepared staff for auditsMaintained and verified records for accuracy and completenessDeveloped and implemented Policies, SOPs and SSOPInvestigated deviations found in plant process or resulting from customer complaintsProvided food safety training for new and existing employeesProvided technical expertise and direction regarding product quality, food safety, and Good Manufacturing PracticesPerformed mock recallsReviewed labels for accuracy and complianceWorked with government agencies addressing food safety and quality issues as required

Post-Graduate Diploma, Post-Graduate Diploma In Qa/Qc In The Pharmaceutical Industry

Bachelor Of Science Degree, Microbiology Honours