KACHARU BABRU GAIKWAD
Mumbai
Summary
Adept at steering complex Quality IT systems within Cipla Ltd., I excel in aligning with GxP and GAMP5 guidelines, showcasing exceptional project management and people leadership. My tenure is marked by successful LIMS upgrades and rigorous compliance achievements, underpinned by profound knowledge of regulatory requirements and a collaborative spirit.
Overview
20
20
years of professional experience
Work History
CSV Lead
Cipla Ltd.
Mumbai
06.2014 - Current
- Ensure that Quality IT GxP system implementations in the organization comply with regulatory guidelines such as 21 CFR Part 11, EU Annexure 11, etc.
- Quality IT policies, SOPs, and manuals are required for the implementation of quality IT systems, and they ensure that policies are available to all stakeholders by uploading and maintaining them on CipDox.
- Ensure all the impacted SOP/ policies are modified before implementation of new IT systems
- To monitor and ensure that Quality IT GxP systems are adequately validated as per predefined categories and regulatory guidelines and standards, such as 21 CFR Part 11, EU Annexure 11, and GAMP5.
- To ensure that quality IT documents and vendor audit documents are available for all GXP computerized software for providing technical support, timely resolutions, and documentation.
- To perform, monitor, and conduct Internal Audit, a GAP analysis, and a corrective plan are in place.
- Review the GxP system, business workflow, and GAP assessment to strengthen the process/system.
- Evaluate new technologies and quality IT systems to implement automation for better traceability, accountability, and strengthening of the quality system, and better compliance.
- Provide technical guidance in automation.
- Evaluate vendors, and conduct a vendor audit.
- Selecting the Quality IT Systems.
- Initiate new automations in Cipla for simplification and better compliance.
- Identify the areas of improvement.
- Simplify the complex process, and automate the process for system betterment.
- Ensure there is continuous improvement in the deployed Quality IT system for better utilization.
- To oversee aspects of quality IT assurance, including establishing metrics, applying industry best practices, in line with current guidelines, and regulatory standards.
- Perform enhancement, qualification, and validation of existing IT systems to achieve compliance with the latest regulatory requirements.
- Prepare and review business process-related change requests, and ensure compliance with the change management procedure.
- Review and approval of the impact assessment of any changes related to configuration, development, and user roles.
- Preparation and review of validation documents for Quality IT systems, as per the standard operating procedure for the Validation of Computerized Systems.
- Review of the quality management system to achieve compliance with regulatory requirements.
- Review of the investigation of non-conformance, the impact of the non-conformance, and the action plan for the non-conformance through the deviation tool.
- Review of corrective and preventive actions for any nonconformance.
- Key Dimensions: Production system review: Site review of production and quality systems with respect to regulatory requirements related to CSV and compliance as per FDA 21 CFR requirements.
- LIMS Instrument Connectivity: File-based instrument connectivity and Moxa-based instrument connectivity.
- Implementation of GxP Quality Systems: LIMS, eTDS, CLEEN, APQR, eLOG, CipDox upgrade, emSigner, etc.
- Implementation of Chromeleon-LIMS connectivity across all the Cipla and its associate sites.
- Cross-functional system CSV, team management, and training to induce critical thinking.
- Managed the project for upgrading LIMS maintenance patches with success.
Cipla Ltd.
01.2011 - 06.2014
- Work planning and allocation of work to analysts
- Review of Microbiological test results
- Timely investigation and closure of Non-conformances like OOS, OOT, Deviations
- Supported in Regulatory audits / audit compliances
Cipla Ltd.
03.2005 - 12.2010
- Testing of various microbiological testing’s e.g., Environment monitoring in Sterile areas, Sterility testing, Bacterial endotoxin testing, Disinfectant efficacy testing, Water Testing
- Performed various non routine activities in microbiology lab, Autoclave validation, DHS validation, Method validation of MLT, Water etc
- Review of microbiological tests results e.g., Environment monitoring in Sterile areas, Sterility testing, Bacterial endotoxin testing, Disinfectant efficacy testing, Water Testing
Education
M.Sc. - Microbiology
University Department of Microbiology
Pune03.2003
B.Sc. -
Mahatma Phule College of Science
Pune03.2001
Skills
- Knowledge of GxP requirements as per GAMP5 guidelines
- People management skills
- Task prioritization
- Problem-solving abilities
CERTIFICATIONS
- LIMS Admin1 Training from Labware UK.
- Prince training for Project management.
Personal Information
- Date of Birth: 25 June 1979
- Marital Status: Married
Languages
Marathi
First Language
English
Proficient (C2)
C2
Affiliations
- Cricket lover
- Music listener
Timeline
CSV Lead
Cipla Ltd.
06.2014 - Current
Cipla Ltd.
01.2011 - 06.2014
Cipla Ltd.
03.2005 - 12.2010
M.Sc. - Microbiology
University Department of Microbiology
B.Sc. -
Mahatma Phule College of Science
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