Kavithareddy K

QARA adept with over 4 years of progressive experience, beginning as a Quality Executive and progressing to Manager - Quality Assurance, with competence in team management, QMS, and cGMP compliance. Expertise in pharmaceutical primary packaging and Class I M medical devices, with complete process knowledge and managing quality management systems as per EN ISO 13485:2016, ISO 15378:2017, IMDR 2017 & EU MDR 2017/745.

Manager, Quality Assurance at Precispharma Containers Private Limited (2022-01 – Present)

• Lead Quality Assurance operations for pharmaceutical primary packaging and Class I medical device manufacturing.
• Maintain and improve Quality Management Systems in compliance with ISO 13485, ISO 15378, EU MDR 2017/745, and IMDR 2017 requirements.
• Manage CAPA systems, deviation investigations, root cause analysis, and OOS handling.
• Coordinate and lead customer audits, supplier audits, internal audits, and regulatory inspections.
• Prepare and review technical documentation, CE marking files, Declaration of Conformity, and IFU documentation.
• Execute and monitor validation activities including IQ, OQ, and PQ protocols.
• Conduct risk assessments in accordance with EN ISO 14971:2019 standards.
• Support Post-Market Surveillance, complaint handling, and mock recall activities.
• Collaborate with cross-functional teams to improve operational efficiency and compliance readiness

Master of Science in Microbiology – University of Mysore, Manasa Gangotri Campus (2018 – 2020)

Bachelor of Science in Biochemistry, Zoology and Microbiology – Maharani Lakshmi Ammanni College for Women, Bangalore University (2015 – 2018)