Data Entry Computer System
Resume:
Sunaina Mahendru
**********@*****.***
Bristol Meyer Squibb (BMS) Apr 2022 – Present
Computer system Validation Specialist
Followed CSV Master Plan to prepare, review and approve Validation deliverables for computer system as per GXP, GMP procedures.
Created, revised and updated control system SOPs in support of protocols.
Co-ordinated with IT to ensure that all functional area activity complies with best quality practices including the computer system validation processes and documentation.
Worked closely with team members to develop recommendations on ways to improve the data capturing process.
Authored the Risk Assessment reports for all the computer systems.
Involved in developing, executing, and documenting SOPs, Test Plan and Test Scripts and final report review and approval.
Authored, reviewed, updated, and executed validation protocols including IQSTUAT.
Updated and assisted in the development of the Traceability Matrix, URS and UAT.
Involved in the GAP analysis for the verification of user requirements documentation.
Authored and reviewed user manuals and summary reports.
Authored the Periodic Review of computer systems.
Revised Audit Trail and user system roles document based on the system requirement.
Experienced in creating risk assessment, test plan and executing the spreadsheet validation.
Involved in initiating the Proactive initiative and Deviation request.
Experienced in exporting report from the Valgenesis, Infinity, Veeva, eQRMS, SNOW tool.
Evergreen Hospital Nov2022 – May2023
Pharmacy Technician-Med Reconciliation
Performing tasks like Data Entry, trouble shoot third party discrepancies as and when needed.
Completes medication order and all assigned tasks on time.
Responding to customer complaints, inquiries or requests for information and/or service and ensuring customer priority and satisfaction.
Working with pharmacy associates engaged in sales work and the prescription filling process, including maintaining and taking inventory and keeping accurate records.
Experienced in automated cabinet restocking and troubleshooting, running reports and crediting the medications in the pharmacy system.
Experienced in operating daily automation necessary to complete task.
Data entry, Compounding, drug preparation, labeling and Other duties as assigned by the pharmacist.
Assist in training new staff and helps other areas when needed
Works with patients to get all the info. About their drug history, duration and any interactions.
Experienced in verifying all the patients info. With caregivers or pharmacy or any other source if required
Seagen, Inc. Jan2021 – Mar 2022
Quality Assurance Validation
Ensure that all facility assets listed in validation documentation have a TMX (Traceability matrix) drafted.
Ensure all drafted TMXs have test scripts populated for each requirement. Perform initial review of applicability of testing to requirement. Track when return to service testing is complete and inform SOs / SVAL that TMX is ready for approval.
Assist SOs with TMX updates to RTS testing. Assist Materials Management with drafting and approval of TMXs (MM TMXs were not included in the scope of the Expansion Project)
Assist with updating QSISR with TMX numbers – current draft will list documents as “TBA (to be approved)”.
Draft TMX work instruction – create work instruction document in QDM for future TMX generation and approval.
Assist Materials Management with TMX generation – MM was not in scope for expansion project, will need TMXs.
Archive executed protocols within Quality Doc Control. Assisted with indexing of all documents within Doc Control. Scanning and uploading docs to veeva.
Executed batch records and logbooks to requesting facility (MFG, FAC)
Maintain vendor list information and keep track of all change notices
Initiate vendors change form and route for archival to other team members of different groups (MQA, MSAT, MFG, QA and QC) for compliance team
Keep tracking of all VCN and once it’s completed, route for archival and documented in spreadsheet.
Listing tracking record to compliance sharepoint
Maintain scanned copies of all Validation and compliance to different folders according to the subcategories. Assist team members if they require any doc.
Walgreens, Kirkland, WA Dec 2020– Feb2023
Pharmacy technician
Dispensing prescriptions by following federal and state laws and as per company’s policies and procedures.
Consult with physicians and patients with regard to medication dosage, drug interactions, medical equipment, disease management and potential side effects of prescription and OTC medications.
Performing tasks like Data Entry, trouble shoot third party discrepancies as and when needed.
Responding to customer complaints, inquiries or requests for information and/or service and ensuring customer priority and satisfaction.
Working with pharmacy associates engaged in sales work and the prescription filling process, including maintaining and taking inventory and keeping accurate records.
Communicating with other members of the company’s Management team.
Verification of prescriptions and dispensing of medications. Also includes assigning tasks, training of pharmacy staff and overseeing the running of pharmacy as per state and federal laws and regulations.
Data entry, Compounding, drug preparation, labeling and Other duties as assigned by the pharmacist.
Flextronics Jan 2019 – Mar 2019
Validation engineer
Assisting in development, implementation, and enforcement of computer validation policies and practices protocol, execution work, and final report review and approval.
Responsible for developing, implementing and updating quality procedures, work instructions, installation, operational and process validation protocols and plans, ensuring regulatory compliance with cGMPs of all regulatory agencies.
Developed validation and quality assurance documents including templates for validation related documentation such as Validation Protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) from CSV Compliance's and regulatory requirements aspects.
Aspects of 21 CFR Part 11, GAMP, GxP’s (especially GDP’s), various approaches to testing and good practices regarding objective evidence documentation were given importance during the training sessions.
Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA)
Hill rom Jan 2018 - Dec 2018
Validation engineer
Documentation/reviewing validation activities as per GDP for regulatory agency submission.
Writing, reviewing and updating the validation master plan.
Responsible for analyzing and reviewing validation deliverables like User and functional requirement specifications.
Writing, Reviewing and documenting various equipment qualification protocols including IQ, OQ and PQ protocols
Predict the accuracy, precision, repeatability and reproducibility.
Collaborates with Quality management team within the organization to ensure that all functional area activity complies with best quality practices including the computer system validation processes and documentation.
Assist in document management system execution, Standard Operating Procedures (SOPs) generation, review, and approval process.
Punjabi University, Patiala May 2015-Sep 2017
Research Experience
Design, synthesis and biological evaluation of coumarin Derivatives.
Experienced in using a wide range of characterization techniques such as 1H NMR, 13C NMR, mass spectrometry, infrared spectroscopy and UV spectroscopy.
Being a medicinal chemist, I also have experience in the in vitro biological evaluation of the molecules. The assays I have performed were based on ELISA, UV spectroscopy, colorimetry, agar well diffusion and broth microdilution.
With the results of the biological evaluation in hand, I proposed the structure-activity relationship for the synthesized class of compounds. The establishment of a structure-activity relationship helped me to clarify many basic concepts of organic chemistry such as electronic effects and steric effects.
I have also carried out animal studies to evaluate the molecules to check their anti-inflammatory potential on mice model and to analyse the behavioral understanding.
EDUCATION
Master’s in pharmacy (Pharmaceutical chemistry)
Bachelor and Diploma in Pharmacy; PSBTE, Punjab, India.
CERTIFICATION
PTCB Certified in Washington state
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