QA and QC Manager, Validation and Stability Officer, Analytical Development & Stability Officer

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)

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

Accomplishments
* Validated 75% of analytical methods (including methods for cleaning) and equipment
* Achieved 100% CTP in Validation Periodic Review
* Governed team's CAPAs, SOP revisions, risk assessments, deviations, and Change Controls. 95-100%
compliance every month.
* Supported the QC Laboratory in L3 and L4 audits which resulted in a successful audit (Global
Employee Recognition for Teamwork)
* An active member of the Product Lifecycle team and awarded for teamwork in the improvement of PLM
(Global Employee Recognition for Innovation)
* Achieved 100% CTP in SOP and monographs/methodology review

Responsible for testing raw materials and finished goods using analytical equipment and wet
analysis.

Accomplishments:
* Coordinated and performed analytical tests to comply with established standards and
specifications.
* Maintained an organized, safe, and efficient laboratory environment to minimize accidents and
prevent cross-contamination.
* Repaired, calibrated, and safely operated laboratory equipment to reduce costly instrument
downtime.
* Backed up Microbiologist for one month while searching for a full-time Microbiologist.
* Reduced backlogs in Stability Program by checking spreadsheets as per the plan