Deepthi Kondabolu Email & Phone Number

Mildura, Victoria, Australia

Manages the Quality portfolio and Risk Management framework.Generates and reports Quality metrics, addressing adverse trends to the Head of Quality.Reviews, approves, and verifies testing plans and records for raw materials and products.Assesses and disposes of raw materials and finished products, escalating major issues.Handles document issuance, batch records, and product release.Manages deviations, complaints, and corrective actions; performs investigations and CAPAs.Conducts vendor assessments and audits.Reviews and approves investigations, risk assessments, specifications, and procedures.Ensures service providers and outsourced activities are monitored and compliant.Maintains equipment qualification, training programs, and personnel management.Oversees document management, GxP compliance, and liaises with regulators.Performs self-inspections and supports continuous improvement and management reviews.

Hyderabad, Telangana, India

I have extensive experience with various applications, including SAP, Shape LIMS, and data analytics tools such as Qliksense (AMQ & QANTO). I am proficient in AGILE for change controls, 1QEM/Trackwise for Quality Events/Deviations, and Alteryx. In my role as an analyst on the Environmental and Health Safety Monitoring team, I supported investigations related to sterile formulations. I am a super user of SAP and NOVASOL. Additionally, I contributed to the stability team on a shelf life reduction project and was involved in writing and reviewing testing monographs. I also worked with the release team to analyze transport risk assessments and temperature excursions during the transit of finished products, and I am well-versed in CSV (Computer System Validation).

Shamshabad, Telangana, India

As a QA Executive specializing in Quality Management Systems (QMS), I was responsible for initiating change controls and managing deviations. My role included conducting self-inspections and internal audits, reporting non-conformances, and initiating Corrective and Preventive Actions (CAPA). I performed quality risk management and investigated deviations in collaboration with cross-functional teams to determine root causes. Additionally, I served as a training coordinator, overseeing the onboarding of new employees and providing training on GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) guidelines.

Hyderabad, Telangana, India

I have experience working in an Oral Liquid Formulation unit, handling equipment such as bottle washing machines, filling machines, and sealing machines, as well as overseeing utility validation activities (DQ, IQ, OQ, PQ) for AHU systems. I was responsible for preparing protocols and conducting process and cleaning validations for various products. My role also included participating in the analytical review of Batch Manufacturing Records (BMR) and Batch Production Records (BPR) and batch release. I initiated and managed change controls, deviations, and market complaints, performed investigations to identify root causes, and implemented CAPAs accordingly. Additionally, I conducted vendor qualifications and assessments following procedures, reviewed artwork, and managed document issuance and retrieval with adherence to Good Distribution Practice (GDP) standards.

Master'S Degree, Pharmacy, 89.9%

Activities and Societies: Recieved Academic Excellence Awards, Seminar and poster presentationsProject on Novel drug delivery: Development.

Bachelor'S Degree, Pharmacy, 83.06%

Activities and Societies: QSAR Seminar; Published an Article in EJBPS 2016, Volume 3, Issue 9, 276-289 " Synthesis and Screening.