ASHOK CHIDIPOTU

• Performing wet analysis like LOD, ROI, Heavy Metals, etc.,

• Preparation of Working Standards and timely monitoring of Reference standards.

• Finished product analysis of Oral dosages, Transdermal Patches, Injectables and its Raw materials.

• Responsible for complying for GLP in the department.

• Attending training programs like cGMP, Analytical related seminars as well.

• Experience supporting OOS/OOT investigations and deviations in raw materials and finished products.
• Monitoring of GLP Compliance in the Quality Control Lab.

• Performing all kind of Analysis by HPLC and Performing Validations of Analytical methods HPLC assigned by Group leader.
• Checking and maintaining of laboratory records.
• Trouble shooting of instrument whenever required.
• Handling of OOS & OOT Investigations in raw materials and finished products.
• Handling laboratory incidents and deviations & notifications in the team. Preparation and implementation of documents related to GMP.
• Instrumental analysis handled by using HPLC, Polari meter, Karl-fisher, Auto titrator, etc. by using advanced software’s.
• Worked effectively in fast-paced environments.
• Skilled at working independently and collaboratively in a team environment.
• Proven ability to learn quickly and adapt to new situations.
• Lab compliance related to standalone Instruments and Empower-3 Chromatography data station. Monthly review of audit trials for the standalone instruments.
• Hands-on experience supporting and coordinating regulatory inspections, including: USFDA, MHRA, TGA, ANVISA, and WHO audits.
• Strong understanding and execution of cGMP documentation practices, laboratory compliance, and GLP monitoring.
• Hands on experience with analytical instruments (HPLC, GC, FT IR, dissolution, particle size analysis, KF titration, autotitrator, polarimeter) and proficiency with analytical software (Empower, Chromeleon, LabSolutions, LabWare LIMS)

• Preparation and Implementation on Laboratory SOP’s and it’s Software management and Analytical Validations and routine analysis.
• Creation of New users in LIMS (Laboratory information Management system)
• Creation of calculations and implementation of standards and impurity standards in LIMS
• Masters creation, Maintaining the laboratory chemical usage.
• Specifications and standard testing procedures modifications
• Approval of sample management, Generation of Analyst Qualification number.
• Uploading SOP'S into the software, Evaluation of training records.
• Using NINCHILON PRO Training and Assignment summary report generation.
• Conduct investigations and deviation experiments under group leader supervision, document observations and prepare reports as needed. Respond to data reviews and provide professional support for audit responses, ensuring timely and compliant follow‑through.
• Comply with all applicable SOPs and laboratory procedures to ensure adherence to regulatory and internal quality standards. Perform QC testing using the LIMS system for sample management, data entry, and results reporting.
• Maintain accurate laboratory notebooks and prepare ARD/QC reports in compliance with documentation and data integrity requirements.

• Performing analytical testing, method development, validation, and instrument operation to support product development, quality control, and regulatory compliance for multiple dosage forms within a cGMP/GLP pharmaceutical environment.
• Perform quality control testing for in‑process materials, finished products, and stability samples across multiple dosage forms, including oral solids, topical formulations, and transdermal systems.
• Conduct analytical testing, including assay, related substances/impurities, blend and content uniformity, particle size analysis, dissolution testing, and residual solvent analysis using appropriate methodologies.
• Operation analytical instruments, including HPLC, UPLC, GC, particle size analyzers, dissolution apparatus, FT‑IR, UV‑Vis spectrophotometer.