Quality Control Regulatory Compliance

Gopi Krishna Makkena

SR CHEMIST

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

Ph: 978-***-****

https://www.linkedin.com/in/gopikrishna-makkena-aa5a36260

PROFESSIONAL SUMMARY

* ***** ** ********** ** analyzing and validating methods within the QC for HPLC technique with the goal of updating and improving the existing methods especially in final/finished products.

I handled LC-MS for impurity profiling, API identification, and method validation under cGMP guidelines. I performed instrument operation, troubleshooting, and ensured accurate documentation for regulatory compliance.

Experience in CGMP, GLP, FDA regulated environment and follows GDP.

Empower to initiate and process data.

HPLC and GC setup, troubleshooting and basic maintenance.

Perform timely & accurate quality control analysis using test established.

Perform calibration of equipment.

Assist in troubleshooting issues with in-process, intermediate and finished products.

Special interest in method development process to enhance the quality of the product.

Finding new ways to improve product's stability and to achieve desired results.

Proper handling storage and disposal of samples used in HPLC analysis as well as maintaining accurate records of sample information.

Identifying and resolving issues related to HPLC instruments to maintain the integrity of test results.

Corrective action and preventive action.

Detection if OOS results can be identified during testing whether its for the purity potency or other quality attributes of a product.

TECHNICAL SKILLS

Develop and implement standard operating procedures to support the quality system and laboratory functions. Understand and utilize good laboratory practices In a GMP environment. Routinely prepare sample solutions, standards & reagents in accordance with defined testing procedures

UV-Vis Spectroscopy Analysis: Conducted quantitative analysis of compounds by measuring their absorption spectra using UV-Vis spectroscopy. Performed concentration determinations using Beer-Lambert’s law and developed calibration curves for accurate quantification. Analyzed reaction kinetics by monitoring time-dependent absorbance changes, ensuring the reproducibility and reliability of results.

IR Spectroscopy Analysis: Operated FTIR spectrometers to identify functional groups and characterize organic and inorganic compounds Interpreted IR spectra to confirm molecular structures and detect impurities in synthesized materials. Gained proficiency in sample preparation techniques (e.g., ATR, KBr pellet method).

PROFESSIONAL EXPERIENCE

Apta Pharma Inc. Jan 2023-Present

Experienced in Quality Control testing with Karl Fischer Titration for moisture content analysis, HPLC for component separation and quantification, and GC for volatile compound analysis. Proficient in performing OOS investigations, identifying root causes, and implementing corrective actions to ensure product quality and compliance. Skilled in troubleshooting HPLC systems, reviewing data, and ensuring adherence to GMP/cGMP standards.

Lee Pharma Ltd. Jan 2021 - May 2022

Sr Chemist

Stability Analysis and OOS Investigations (Phase-1 & Phase-2) In QA Department AQA also. And working standard qualifications, Customer complaints & Marketing Samples are followed in QA Department.

Key responsibilities:

Managing the documentation control process to ensure that all relevant documents record and reports maintained and accessible.

Working closely with other departments quality control and regulatory affairs to ensure alignments and coordination in quality assurance efforts

Evaluating and qualification suppliers and vendors of analytical equipment’s reagents and materials to ensure they meet quality standards.

Participating investigation of OOS results deviation and incidents to identify root cause and implements corrective actions.

Carefully reviewing all relevant data including raw data testing procedure and any associate documentation to identify inconsistencies

Divis Laboratories June 2019 - Dec 2020

Quality Control HPLC Analyst

Analyze and validate methods within the QC for HPLC technique with the goal of updating and improving the existing methods especially in final/finished products.

Key responsibilities:

Properly preparing samples for analysis which may involve dilution filtration or extraction to ensure accurate results

Operating and maintaining the HPLC and GC instrument including setting up the system calibrating detectors and ensuring proper column installation

Developing and optimized HPLC and GC methods for specific analysis considering factors such as solvent composition column type and flow rate.

Diagnosing and resolving technical issues that may arise during instrument operation or analysis.

Maintaining detailed records of methods procedure and results in compliance with laboratory protocols and regulations

Ensuring the accuracy and reliability of results by following established quality control procedure and standard.

Shree Icon Pharmaceutical Industry August 2017 - December 2018 Junior Analyst

Developed strong laboratory skills including pipetting, sample preparation and general laboratory safety procedures.

Understand principles of quality control and ensure that analytical methods meet regulatory requirements and standards.

Maintain detailed record of work including methods, results and any deviation from standard procedure.

Good manufacturing and good laboratory practices are ensured.

Employment

QC Analyst at Divis Laboratories

Sr Chemist at Lee Pharma.

Analyst at Shree Icon Pharmaceuticals.

Education

Masters in Analytical Chemistry from Sacred Heart University, Connecticut.

Bachelor of Science from Acharya Nagarjuna University, India 2017.

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