Krista Evans Email & Phone Number

Brockville, Ontario, Canada

Responsible for ensuring cGMP Compliance is maintained while also improving efficiencies.

Brockville, On

Perform external audits of vendorsHost internal audits from customers and regulatory agenciesReview Annual Product ReviewsEnsure compliance to regulatory requirements for GMPs

Brockville, On

Managed and executed functions related to Quality Control for the introduction of an $11 million business into TrilliumLed project for introduction of USP<232> and USP<233> general chapters into the QC laboratoryCreated custom calculations and reports in the Empower Chromatography systemLed investigations into Out of Specification and Suspect resultsPerformed compendial review and updated methods to ensure accuracy with Pharmacopeias Created and modified analytical work cards (AWCs), standard operating procedures (SOPs) and Work Instructions (WINs)Updated specifications in Trillium's LIMS system for raw materials to ensure material specifications were aligned to compendial and customer specificationsCreated and reviewed documentation for compendial verification and method transfers Assisted analysts in troubleshooting method issuesPerformed data review on raw materials, packaging components and finished drug productPrioritized work schedule for analysts when supervisor was not available

Toronto, On

Performed data reviewWorked independently and with others while performing analytical testingCompleted write-ups in a timely mannerLed R&D Communication Lead team to disseminate information to R&D employeesOversaw maintenance of R&D website and updated using MOSSCompleted internal training courses in leadership skillsCharted daily progress to manage time more effectivelyInvestigated the cause of an increasing known peak in degradation product test to improve testing procedure

Toronto, On

Acted as business lead for implementation of LabWare LIMSWorked independently and in team while performing analytical testingFinished write up in timely mannerOversaw maintenance of R&D websiteHelped maintain column inventoryAssigned instruments to group members on a weekly basis

Toronto, On

Helped determine cause of ghost peak in HPLC chromatogram for dissolution testWorked independently and in team while performing analytical testingActed as Communication Lead to convey information between management and employeesTook internal training courses for presentation skills, time management and communicating non-defensivelyVolunteered to be secretary during group meetingsCharted daily progress to manage time more effectively