Highlights:

Skills:Quality Control Analyst, LC-MS Chromatography, Quality Compliance, GMP & Audit related knowledge

Senior Executive Quality Control 01/2023 - current
Zydus Lifescience Ltd, Ahmedabad, Gujarat India
Industry: Pharmaceutical
Performing Various analysis on the Quality Control Lab.
Quality Control Section: Managing and analysis finished sample, stability and In process sample as per standard procedure. Good hand on experience on Analytical instrument like HPLC, UV, pH Meter, Analytical Balance etc. Well versed with analytical method like SEC HPLC, RP HPLC, IEX HPLC, Protein A. Reporting to QC coordinator on Daily basis, Ensure compliance of GxP computerized system as per site SOPs/Policies. Quality Compliance: Software investigation, Member of internal audit, Data Integrity, Review of LER and Incident, vendor audit, Risk assessment and their management. Actively involved in Lab compliance to ensure authenticity and integrity of electronic data as per 21 CFR part 11. Preparation of SOP’s and STP.--
Senior Executive Quality Control 06/2022 - 01/2023
Syngene International Limited, Bangalore, Karnataka India
Industry: Pharmaceutical
Quality Control Analyst in Chromatography by HPLC
Quality Control Section: Managing and analysis finished sample, stability and In process sample as per standard procedure. Good hand on experience on Analytical instrument like HPLC, UV, pH Meter, Analytical Balance etc. Well versed with analytical method like SEC HPLC, RP HPLC, IEX HPLC, Protein A. Reporting to QC coordinator on Daily basis, Ensure compliance of GxP computerized system as per site SOPs/Policies. Quality Compliance: Software investigation, Member of internal audit, Data Integrity, Review of LER and Incident, vendor audit, Risk assessment and their management. Actively involved in Lab compliance to ensure authenticity and integrity of electronic data as per 21 CFR part 11. Preparation of SOP’s, STP and QMS.--
Executive Quality Control 05/2019 - 05/2022
Intas Biopharmaceutical Limited, Ahmedabad, Gujarat India
Industry: Pharmaceutical
Quality Control Analyst
Quality Control Section: Managing and analysis finished sample, stability and In process sample as per standard procedure. Good hand on experience on Analytical instrument like HPLC, UV, pH Meter, Analytical Balance etc. Well versed with analytical method like SEC HPLC, RP HPLC, IEX HPLC, Protein A. Reporting to QC coordinator on Daily basis, Ensure compliance of GxP computerized system as per site SOPs/Policies. Quality Compliance: Software investigation, Member of internal audit, Data Integrity, Review of LER and Incident, vendor audit, Risk assessment and their management. Actively involved in Lab compliance to ensure authenticity and integrity of electronic data as per 21 CFR part 11. Preparation of SOP’s and STP.--

Mayur Gondaliya CV Curriculum vitae