Key Responsibilities:• Author and review analytical method validation/verification/transfer/study protocols and reports. Design the study approach to ensure the method validation/verification/transfer meet the method’s intended purpose and its’ requirement as per ICH guidelines or pharmacopoeia.• Plan and perform analytical method validation/verification/transfer/study as per protocol, within the timeline.• Collaborate with Quality System team to author and review in revision and continuous improvement of all relevant SOPs/EOPs/Specifications (Standard Test Procedure) in accordance to cGMP or pharmacopoeia requirements and initiate Change Controls. • Establish periodic review of the Analytical Method Lifecycle Management in QCA laboratory. Perform trending of method system suitability with control parameters and related QMS element and author the Analytical Method Lifecycle Management reports.• Perform investigation to any non-conformance in the QCA laboratory using appropriate investigation tools. Author the investigation report and other related documents such as Risk Assessment, CAPA and Change Management. Responsible in the initiation and timely closure of the QMS records in Trackwise system.• Support Standard Management team by performing analytical testing for internal working standard qualifications for multiple Insulin products. Author and review the internal working standard qualification reports and CoAs.• Manage the archival of raw data and reports.• Mentor and train junior team member for Analyst Qualification on various analytical methods involving HPLC and AAS.• Responsible to provide technical know-how to Finished Product analysts upon the completion of analytical method validation, verification or transfer activity.• Participate in internal and external audits of various regulatory bodies such as USFDA, EMA and NPRA.Achievement:• Certificate of Commendation for Outstanding Performance and Lasting Contribution in Q4 FY’ 23 (April 2023)

Key Responsibilities:• Execution of analytical method validation, method verification, method transfer and method study for existing and new products within given timeline.• Prepare analytical method validation, method verification, method transfer and method study protocols and reports.• Author and review Change Controls as well as Test Methods and Specifications for Finished Product and Raw Material routine testing.• Provide technical support and training to Finished Product team as required.• Collaborate with Standard Management team by contributing in execution and documentation for qualification of standard activity.• Involve in investigation of laboratory incidents, deviations and OOS. • Responsible for archival of documents and raw data of analytical method validation, method verification, method transfer and method study performed.• Responsible for laboratory management such as chemicals, glassware, micropipettes and equipment for Validation team.• Key personnel to provide training on methods and instruments to other team members.• Ensure compliance of all the activities with international standards and requirements as per current GMP, GLP, GDP and safety regulations within the laboratory.• Participate in internal and external (EMA, FDA, NPRA and Viatris) audits.Achievements:• Certificate of Recognition for Outstanding Performance and Lasting Contribution (August 2021)• Certificate of Commendation for Outstanding Performance and Lasting Contribution in Q2 FY’ 22 (October 2021)• Certificate of Commendation for Outstanding Performance and Lasting Contribution in Q2 FY’ 22 (January 2022)

• Performed in-process and finished product testing of drug substance and drug product and reported results as per current quality requirement.• Responsible in compilation of analytical data and results.• Participated in establishment, verification and qualification of analytical methods.• Drafted technical study reports and prepared analytical record templates.• Maintained proper documentation (records and laboratory notebook) for all analytical experiments performed as per Good Documentation Practices.• Supported QC related activities as well as participated in OOS investigation.

• Prepares and dispenses prescribed medications to patients under the direction of a licensed pharmacist• Educates patients with information on their prescriptions• Performs administrative tasks, including receiving and inputting prescription orders and operating cash registers• Acquires good interpersonal skills dealing with patients or customers

• Completed an eight-week clinical laboratory internship• Worked in 6 departments: Fluid & Excretion, Chemistry, Histopathology, Microbiology, Hematology, Transfusion• Performed tests for patient diagnosis and treatment by operating laboratory equipment in each of the departments