Nirali Khamar Email and Phone Number
Experienced Senior Executive in Quality Control with a proven track record in managing the finished product section. Proficient in overseeing analytical research activities, leading documentation efforts, and ensuring compliance with regulatory standards. Skilled in utilizing advanced instruments such as HPLC, UV/Vis Spectrophotometer, and FTIR. Successful in handling various regulatory audits, demonstrating expertise in data integrity, GMP, GLP, and SOPs. Accomplished in preparing comprehensive records of analysis, Certificates of Analysis (COA), and working on software platforms like LIMS, SAP, and PharmaCloud. Effective in coordinating cross-functional departments for timely planning and execution
Biomatrix Healthcare Pvt. Ltd.
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Sr. Executive - Analytical Development LaboratoryBiomatrix Healthcare Pvt. Ltd. Nov 2023 - Present*Lead documentation efforts for analytical research activities, ensuring accurate and compliant record-keeping.*Oversee the preparation of comprehensive record of analysis (ROA)/Test data sheets and testing protocols following approved standard test procedures and methods of analysis.*Manage the timely upload of documentation to the PharmaCloud software.*Ensure master ROA/test data sheets are prepared, updated, and submitted to Good Laboratory Practices (GLP) standards.*Supervise the preparation of Certificates of Analysis (COA) and their entry into PharmaCloud for analytical results.*Create , review and approve laboratory standard operating procedures (SOPs) to maintain compliance.*Collaborate in the preparation of technical documents, including analytical reports and protocols.*Participate in the preparation of specifications, standard test procedures, and documentation related to change control, Monograph, Master Formula Record (MFR), and drug master file. -
Senior ExecutiveCadila Pharmaceuticals Limited Dec 2008 - Mar 2023Ahmedabad, Gujarat, India*Handle receiving and planning of various samples for analysis and timely release.*Ability to plan the work and handle man power utilization efficiently. *Faced regulatory audits like USFDA, MHRA, TGA, MCC, WHO (Geneva), EUGMP, MCAZ, UGANDA Saudi Arabia and Ministry of health IRAN and ANVISA etc. Ensure the compliance in quality control Laboratory e.g. data integrity, cGMP, cGLP, STPs, SOPs and specification. *Successfully faced various regulatory audits with major and supporting role in Q.C. *Involved in the preparation of regulatory audit documents and ensuring that the system and compliance is in place. *Identified the root cause of the laboratory investigation and deviation. Compliance of regulatory audit.
Frequently Asked Questions about Nirali Khamar
What company does Nirali Khamar work for?
Nirali Khamar works for Biomatrix Healthcare Pvt. Ltd.
What is Nirali Khamar's role at the current company?
Nirali Khamar's current role is Sr. Executive | Quality Control | Pharmaceutical Products | Analytical Methods | Documentation.
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