Naresh Raikot

About Naresh Raikot

As an FDA-approved Quality Assurance professional with over 13 years of experience in Quality Assurance, Analytical, API & formulation Manufacturing, and R&D formulations, I have honed my expertise in ensuring compliance with regulatory standards and driving operational excellence. Currently serving as a team manager, I have successfully led cross-functional teams and implemented quality improvement initiatives that have enhanced product quality and streamlined processes. With a proven track record of delivering results, I am passionate about leveraging my skills and experience to drive business success and ensure customer satisfaction. Expertise and technical Skills in Computer System Validation Qualification Vendor Qualification Complaints & Recall DI & Gap Assessment QMS Investigation Trending Risk Assessment Pharmacopoeia Updates Technology Transfer Analytical techniques FDA Submissions Regulatory Audits Analytical Method Validation Stability Data Review Team Management Effective Communication Critical Thinking Problem Solving

Experience

1. Quality Assurance Manager (Qa Head)

   Enaltec Labs Pvt Ltd

   Apr 2021 — Present

   As a QA Head, Manage and monitor the QA team for the US FDA approved analytical lab and R&D formulation. Prepare for all Enaltec sites for inspection readiness, DI and gap assessment. Support and coordinate with the regulatory and CMO team for ANDA filling. Well-acquainted with review, assessment, investigation and approval of all QMS such as OOS/ OOT, Change Control Management, Incident & Deviation management, and CAPA management. Review and approval of Product Development Reports (PDR), Batch Manufacturing Reports (BMR), Master Formula Cards (MFC) and other Formulation data. Supervise, review and approve CSV activities. Prepare for and lead client, vendor, and regulatory audits. Evaluate vendor qualifications and conduct audits for API manufacturing and testing facilities. Ensure the quality management system is implemented and updated. Supervise and approve quality activities and technology transfers. Review and support analytical methods, calibration data, batch release data, Validation Protocol/ Reports, Qualification Protocol/ Reports and stability protocol/data. Handle complaints and recalls, and review/support QMS trending. Maintain GMP documentation, SOPs, specifications, protocol/reports, and formulation data. Communicate with internal and external stakeholders for QA matters. Manage SOP implementation & approval, and archive relevant documents. Conduct team training and development, and ensure effective communication and collaboration within the team.

Education

• Madurai Kamaraj University

  Master of Science (MSc), Chemistry, FIRST CLASS

  2010 — 2012

• Jhunjhunwala college Vintage Point

  Diploma in Regulatory Affairs, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs

  2013 — 2014