Kabilash V
Quality Assurance Specialist
Bengaluru ,KA
Summary
Dynamic professional with a proven track record at Adcock Ingram Private Limited, specializing in regulatory compliance and quality management systems. Expert in SAP S/4HANA, I successfully streamlined manufacturing processes while ensuring adherence to 21 CFR Part 11 guidelines. Strong collaborator with a focus on risk management and product integrity.
Overview
1
1
year of professional experience
4
4
Languages
Work History
Officer
Adcock Ingram Private Limited
11.2023 - Current
- Reviewed and authorized Bill of Materials for each batch manufactured on site.
- Established processes for accurate documentation of batch manufacturing and packaging record in line with critical process parameters.
- Collaborated with vendor management team to ensure monitoring of qualified vendors for batch production.
- Leveraged SAP S/4HANA to streamline and enhance the efficiency and quality of manufacturing and packaging processes.
- Assisted in regulatory audits and inspections, ensuring preparedness and alignment with current regulations.
- Ensured that change controls, deviations, and risk management activities were conducted in accordance with regulatory guidelines (FDA, TGA, etc.) to maintain compliance with GMP and industry standards.
- Maintained and updated batch records in line with revision history to ensure GMP compliance and documentation accuracy.
- Evaluated potential regulatory risks and developed mitigation strategies to maintain product compliance
- Reviewed batch documentation to confirm validation or stability status, ensuring regulatory compliance and accurate batch classification.
- Executed annual stability schedules for all site-manufactured products in accordance with customer requirements and regulatory guidelines.
- Coordinated with production and warehouse teams to manage materials as per monthly plans, ensuring timely availability and adherence to SOPs and quality standards.
- Collaborated with TT, quality assurance, and manufacturing teams to ensure regulatory guidelines are integrated into product development processes.
- Coordinated and tracked regulatory submissions and approvals for new product registrations and life cycle management (e.g., variations, renewals, post-market surveillance
- Ensured adherence to 21 CFR Part 11 guidelines in software usage, safeguarding product quality and maintaining data integrity.
Education
Master Of Pharmacy - Pharmaceutical Sciences
Annamalai University
Chidambaram, TN08.2023
Bachelor Of Pharmacy - Pharmaceutical Sciences
Annamalai University
Chidambaram, TN 08.2021
Skills
SAP S/4HANA
Timeline
Officer
Adcock Ingram Private Limited
11.2023 - Current
Master Of Pharmacy - Pharmaceutical Sciences
Annamalai University
Bachelor Of Pharmacy - Pharmaceutical Sciences
Annamalai University
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