Naresh A Raikot

Experience

• 

  Sequent Scientific Limited

  Jun 2009 - Sept 2010

  Sr Officer-QC

  Performed analysis of all finished products and raw materials according to pharmacopoeias and in-house specificationsPrepared bench reagents and standardized volumetric solutions in accordance with established schedules

• 

  Sitec Labs Pvt Ltd

  Sept 2010 - Mar 2013

  Officer-QC

  Observed good laboratory practices and ensured safe laboratory operations as per standard procedures.Perform Analysis of all finished products, stability samples, and raw materials in compliance with USP, BP,IP, EP, and In-House specificationsCompiled raw data and reports in a timely manner to support quality assessments

• 

  MEYER ORGANICS PVT. LTD.

  Mar 2013 - Jul 2014

  Jr Executive QC

  Managed quality control operations in strict accordance with guidelines and statutory requirementsConducted method validations using HPLC and UV spectrophotometry, preparing comprehensive reports according to ICH guidelinesEnsure proper operation and calibration of instruments and prepare calibration schedules and maintenance contracts.Supervise and review of OOS and joint analysis results

• 

  Analytical Solutions (Part of ALS Limited)

  Oct 2014 - Feb 2017

  Executive QA

  Prepared and reviewed standard operating procedures (SOPs) while overseeing CSV activities.Maintained calibration and maintenance schedules for analytical instruments to ensure reliability.Assisted in the preparation of QMS documents, including change control, deviations, out-of-specifications (OOS), and CAPAs.Supported audits and prepared audit compliance reports to enhance operational transparency and review of audit trails of computerized system and connected instrumentsSupervise and Review of . Analytical Method Validation Protocol/Reports analytical and development reports, extractable leachable data, and stability studies, calibration data. Show less

• 

  Ajanta Pharma Ltd

  Feb 2017 - Feb 2018

  Executive-QA

  Reviewed and approved QMS documents, ensuring adherence to industry standards.Conducted GLP audits, following up on corrective actions to mitigate risksPrepared and reviewed SOPs, IQ/OQ/PQ protocols and reports for instruments and equipment.Supervised and critically reviewed CSV activities to ensure system integrityMonitored and ensured the annual calibration of laboratory instruments and equipment.Supervise and review of Analytical Method Validation Protocol/Reports, calibration data, batch release data, Qualification Protocol/ Reports and stability protocol/data, Specification. Show less

• 

  Endo

  Mar 2018 - Apr 2021

  Sr Associate QA

  Ensured strict compliance with cGMP requirements in USFDA approved analytical and R&D departmentsSupervised, reviewed, and approved CSV activities, enhancing accountabilityConducted internal audits and vendor qualifications, while providing comprehensive training to new employees.Reviewed, approved, and conducted trending analyses of Quality Management System (QMS) documents, including incidents, deviations, and CAPAs using Trackwise software.Supervise, review and approval of Analytical Method Validation Protocol/Reports, calibration data, batch release data, Qualification Protocol/ Reports and stability protocol/data, Specification and STP using Master control software for documentation.Ensured Pharmocopeial Updates and co-ordination with across the site. Show less

• 

  Enaltec Labs Pvt Ltd

  Apr 2021 - now

  Sr. Manager QA

  Led and managed the R&D formulation QA team for regulated and semi-regulated markets and USFDA approved CTL.Conceptualized the establishment of a GMP pilot BE manufacturing facility for Oncology OSD products.Streamlined the reporting of KPIs and shared comprehensive Monthly/Quarterly QRM updates with management.Ensured sites were audit-ready for clients and regulatory inspections, conducting detailed gap assessments &DI Preparation.Assessed vendor qualifications and conducted thorough audits for API manufacturing, CMO, and contract testing laboratories along with Quality Technical Agreement.Supervised and sanctioned quality activities and technology transfer processes.Coordinated and provided support to the RA team for DCGI/USFDA submissions and managed regulatory queries effectively.Supervise investigation, review and approval of QMS documents such as , OOS, Incident, Deviation, CAPA & Change control.Supervise, review and approval of Analytical Method Validation Protocol/Reports, calibration data, batch release data, Qualification Protocol/ Reports and stability protocol/data, Specification and STP.Supervise, review and approval of Product Development Reports (PDR), Batch Manufacturing Reports (BMR), Master Formula Cards (MFC) and other related documents related to technology transfer of formulation and analytical dept for OSD and Injectable Dosage form & Oncology Dosage for Tablets.Facilitated team training and development initiatives, ensuring effective communication and collaboration within the team Show less