Support the QC team in ensuring that all analytical methods and laboratory equipment are in a
validated state. Ensure that all analytical methods and their specifications are aligned with
regulatory requirements. Manage the Stability Program of the site and ensure that team's compliance
is within lead-time requirements
Accomplishments:
* Validated the remaining 25% of analytical methods of the QC Laboratory
* Conducted and supported computer system, process, and cleaning validation of the site
* Created and validated analytical methods for all marker compounds
* Qualified the newly purchased equipment in 1 month
* Validated spreadsheets (excel sheets) for QC Laboratory analysis computations
* Conducted training for the QC Analysts to improve their capabilities.
* Implemented process in proper glassware and HPLC Column Washing which leads to 20% OOS reduction
* Led deviation management concerning analytical methods and equipment qualification
* Active team member of the Validation Working Party
* Governed team's CAPAs, SOP revisions, risk assessments, deviations, and Change Controls. 95-100%
compliance every month.
* Received an award for collaborating with the technical team to deliver the NPI (new product) on
time (Global Employee Recognition for Teamwork)
* Received an award for requalifying equipment in 1 week (Global Employee Recognition for
Accountability)
* Received an award for the commitment to patients and consumers despite the Pandemic (Global
Employee Recognition for Accountability)
* Received an award for conducting Project Management training at the site (Global Employee
Recognition for Development)
* Received an award for providing strong support to LOC IBM
(Global Employee Recognition for Teamwork)
* Received an award for validating a complex method that is urgently needed by the site. (Global
Employee Recognition for Innovation)