Rohan Nivrutti More
New Panvel
Summary
Seasoned Senior Executive with a proven track record at Unichem Laboratories Ltd, excelling in Quality Management Systems and Regulatory Compliance. Demonstrated leadership in guiding teams towards excellence in audit management and method validation. Expert in analytical instrumentation, with a knack for problem-solving and enhancing operational efficiency. Achieved significant quality improvements, fostering a culture of continuous advancement.
Overview
17
17
years of professional experience
Work History
Senior Executive
Indoco Remedies Limited
Rabale
06.2015 - Current
- Oversee the implementation of Quality Management System to align with industry standards and regulatory requirements
- Expertise in handling of Quality Management system documentation like Change Controls, Deviations, OOS, OOT, Incidences and undertake part in the investigations
- Handle customer complaints by investigating issues, documenting findings, and implementing corrective actions to enhance quality
- Coordinated External audits, prepare audit reports detailing findings and recommendations for continuous improvement
- Conduct Internal audits to assess compliance with established procedures and identify areas for improvement
- Collaborate with cross-functional teams to develop corrective action plans based on audit findings
- Prepare documentation for regulatory submissions and ensure timely responses to regulatory inquiries
- Train staff on quality assurance protocols and best practices to foster a culture of quality within the organization
- Review of Analytical Method Validation and Method Transfer Protocols and Reports
- Review of Analytical Method development records
- Review of instrument qualification/calibration and analyst qualification records
Senior Executive
Unichem Laboratories Ltd
Indore
08.2014 - 05.2015
- In charge of Stability Study department for HPLC, work distribution and troubleshooting for IC section
- Preparation, review and submission of Stability Study protocols and reports as per regulatory requirements
- Compliance to queries received from regulatory agencies
- Guide all Team members in calibration of instruments, preparation of standard operating procedures etc
- Checking of raw data generated in line with QA point of view
- Checking of chromatograms, Data sheet, Laboratory notebooks and its submission to Assurance department
- Responsible to investigate laboratory Deviations, Events/Incidences, OOS, OOT, failures and Quality problems in products deciding the Corrective/Preventive actions and effectiveness, providing adequate documented evidence for audit reference
Senior Analyst
Analytical Solutions (CRO)
Rabale
12.2007 - 08.2014
- To arrange and lead Analytical team of Ion chromatography (IC) section
- In charge of all Ion chromatography machines, work distribution and trouble shooting
- Guide all Team members in Method development, Calibration of instruments, preparation of MOA, etc
- Responsible for estimation of Anions, Cations, Transition metals, etc
- And almost all Pharmacopoeial tests specified by IC
- Checking of raw data generated in line with QA point of view
- Checking of chromatograms
- Handling of QA documents like Deviations, Incidents, Change control, CAPA, OOS, OOT, etc
Education
Diploma course -
Regulatory Affairs
01.2018
Master of Science -
Chemistry
01.2014
Diploma -
Industrial Analytical Chemistry
01.2007
Bachelor of Science -
Chemistry
01.2006
Skills
- Quality Management Systems (QMS)
- Regulatory Compliance (ICH Guideline, FDA)
- Audit Management & Internal Audits
- Analytical Instrumentation (HPLC, IC, LCMS, ICP-MS)
- Method Development & Validation
- Troubleshooting & Problem Solving
- Data Analysis & Reporting
- Trackwise software handling for Change control management
- Oasis LIMS software handling for Sample management
- Team Leadership & Training
Auditsexperience
- Has been part of 2 successful USFDA Audit in Indoco Remedies Limited.
- Has been part of 3 successful USFDA Audits in Analytical Solutions.
- Has been part of successful ISO Audits for 7 years in Analytical Solutions.
- Has been part of successful WHO Audit in Unichem Laboratories Ltd.
- Faced Customer Audits as and when required in Analytical Solutions and Indoco Remedies Limited.
Personal Information
- Age: 41
- Date of Birth: 12/14/83
- Marital Status: Married
Timeline
Senior Executive
Indoco Remedies Limited
06.2015 - Current
Senior Executive
Unichem Laboratories Ltd
08.2014 - 05.2015
Senior Analyst
Analytical Solutions (CRO)
12.2007 - 08.2014
Diploma course -
Regulatory Affairs
Master of Science -
Chemistry
Diploma -
Industrial Analytical Chemistry
Bachelor of Science -
Chemistry
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