SHREEVIDYA MAHABALADKA
Senior Executive
Profile
- Proficient in quality control, regulatory compliance, and SOP management.
- Skilled in conducting inspections and audits to ensure accurate reporting of study data.
- Experienced in experimental design, method validation/ verification and FDA documentation.
- An expert GLP professional with experience conducting various Chemistry related regulatory studies following National and International Guidelines in GLP Compliance.
- A proven leader capable of managing technical personnel and training research teams.
- Google Project Management Professional Certificate.
Senior Analytical Research and Development Executive with eight years of experience.
Work Experience
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Senior Executive, Novartis (Contract)
October 2022 – present | Hyderabad
- Planned, executed, and oversaw inspection and testing of products to confirm quality and conformance to specifications and deliverables.
- Conducted comprehensive studies, process-based inspections, and facility-based assessments to ensure regulatory compliance.
- Reviewed Standard Operating Procedures (SOPs) and played a key role in their preparation and updates within the Quality Assurance Unit.
- Inspected documents, including Study Protocols and Reports. Audited such studies and generated study inspection reports.
- Handled deviations/ change control. Reviewed Monthly and Quarterly trends.
- Participated in internal and external audits
- Ensured equipment and related systems are qualified/ validated as per schedule.
- Ensured that reports accurately described methods, procedures, and observations, and that reported results faithfully reflected the raw data of studies.
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Research scientist, Eurofins Advinus Limited
July 2017 – September 2022 | Bengaluru
- Performed analytical method development and validation for the Quantification of drugs.
- Independently operated and calibrated analytical instruments such as (HPLC, GC, GCMS, UV-VIS, LCMS, etc).
- Involved in the activities of Planning, Performing,Supervising, Documenting, Interpreting, Executing,Drawing conclusions and reporting the results along with the Quality Assurance Unit.
- Authored Analytical methods, Protocols and reports for drug analysis- Assay, impurities, Chromatographic purity, and chiral analysis.
- Maintained calibration and standard logbooks.
- Authored white papers, reviewed technical documents, Laboratory notebooks and data packets as per GMP , ICH and good documentation guidelines.
- Provided analytical support to formulation group in order to finalize the Formulation composition and components for new products.
- Assisted in the general operation of the Analytical R&D laboratory, including maintenance of SOP's, training and equipment validation or Maintenance. Proposed weekly SOP discussions, for clarity and ease of procedure implementation.
- Maintained GLP and safety procedures in the lab
Education
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Master of Science(MSc), Industrial Chemistry
Mangalore University
01/2015 - 05/2017 | Mangalagangothri, Konaje
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Bachelor of Science(BSc), PCM
Nehru Memorial College
01/2012 - 08/2014 | Sullia
Analytical Instruments Handled
- Shimadzu and Agilent HPLC prominence I series with empower software
- GC and GCMS - Agilent with Chem station and Empower 3 Chromatography Data Software
- Karl Fischer Metrohm 809 and 795 titrando - tiamo 1.3 Software
- UV-Visible spectrophotometer Shimadzu-uv-1800-uvprobe software
- Liquid chromatography mass Spectrometry machine (LCMS)
- Infrared Spectroscopy - Perkin Elmer
- Sample LifeCycle Management using LIMS and ELPRO monitoring
Internship & Project
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Peak Purity in Chromatography: Investigation Using Phenyl benzoate as Impurity in Diphenylamine
Department of Analytical R and D, ADVINUS THERAPEUTIC LTD, Bangalore.
01/2017 – 05/2017