R D Project Management

Research Analyst

PROFILE

SKILLS

Others

Malligari Shashidhar

**********.*******@*****.***

Telangana,India +918*********

Results-driven professional with over 3 years of experience in analytical chemistry, specializing in HPLC, dissolution testing, and UV-Visible spectrophotometry. Proficient in method validation and familiar with regulatory standards including cGMP, ICH, USP, and EP. Demonstrated expertise in Empower Software, with strong analytical skills, meticulous attention to detail, and effective problem-solving abilities. EDUCATION

PG Diploma Advance

Drug Regulatory Affairs

2024-2025 Jamia Hamdard

University, India

Bachelor of Pharmacy

2015 - 2020 Vishnu

Institute of Pharmaceutical

Education, India

Quality Assurance

HPLC (High-Performance

Liquid Chromatography)

Dissolution Testing

Wet Analysis

Method Validation

(Analytical)

Calibration

(Instrumentation) and

troubleshooting (Analytical

Instruments)

MS Office (Word, Excel,

PowerPoint, Outlook)

Empower Software 3

(HPLC Data Analysis)

LC lab solutions

Analytical Research

EXPERIENCE

High-Performance Liquid Chromatography (HPLC):

Hands-on experience with Waters (Alliance), Agilent

(1100, 1260), and Shimadzu (Prominence) systems.

Software Proficiency: Skilled in Empower Software 3 for HPLC calibration, method validation, and data

analysis.

Dissolution Testing: Experienced with apparatus from leading manufacturers, including Electro Lab (Trust 14) and Lab India (DS 14000). Proficient in UV-Vis Spectrophotometers (UV-2600i, UV-2700i) from

Shimadzu.

Regulatory Compliance: Conducted dissolution testing following USP, EP, and JP methodologies, ensuring

adherence to cGMP, ICH, and regulatory standards.

Analytical Method Validation: Managed analytical

method transfers and validations across eight DPDM projects, ensuring compliance with FDA and ICH

guidelines.

Data Analysis: Expertise in data interpretation and troubleshooting, enhancing overall laboratory

efficiency.

Laboratory Operations: Responsible for FARD

laboratory activities, including cGLP compliance and meticulous documentation.

Formulation Comparisons: Analyzed and compared

formulation data against innovator samples for assay, content uniformity, and dissolution via HPLC.

Team Collaboration: Fostered strong working

relationships through team-building initiatives and effective communication.

Presented research papers at various

seminars and conferences, focusing

on a pharmacognosy project that

involved extracting drugs in churna

form and comparing them with

standard Metformin.

(MSN Labs, 2021 – Present)

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