Summary
Overview
Work History
Education
Skills
Custom
Timeline
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Nithin Kurian

Reading,UK

Summary

Experienced professional with over nine years of experience in Quality Management Systems, Production Management, and Process Improvement in cGMP environments within regulated industries. Proficient in developing and streamlining systems, with a proven ability to enhance operational effectiveness and meet operational goals within cost, time, and quality parameters. Keen understanding of the formalities and implementation of quality systems and complying with the norms of regulatory authorities. Possesses strong research, analytical, problem-solving, training and interpersonal communication skills.

Overview

9
9
years of professional experience
4029
4029
years of post-secondary education

Work History

Technical Investigator

Lonza Biologics
Slough
01.2023 - 03.2025
  • Owned the entire lifecycle of Deviations, Out-of-Specifications (OOS), and Out-of-Trends (OOT), from initiation and investigation to completion and closure
  • Planned, executed, and led root cause analysis with relevant departments
  • Led hoshin meetings, gathered feedback on quality records status and progression, coordinated actions, informed stakeholders, and escalated issues to ensure timely completion of records
  • Managed audit-related queries and customer inquiries, ensuring compliance and maintaining high-quality standards
  • Led process improvement projects not directly associated with deviations or investigations
  • Facilitated and participated in GEMBA walks to identify process improvements and enhance operational efficiency
  • Identified, planned, and executed Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence of issues
  • Executed Risk Management initiatives to ensure compliance and mitigate potential risks
  • Performed final impact assessments of events based on investigation findings to ensure comprehensive resolution and continuous improvement

Senior Quality Assurance Associate

Lonza Biologics
Slough
06.2022 - 12.2022

Quality Assurance Associate

Lonza Biologics
Slough
10.2020 - 05.2022
  • Reviewed documentation generated during manufacturing processes and ancillary areas
  • Audited documentation generated during development and laboratory processes
  • Acted as a point of contact for general queries relating to documentation
  • Identified and reported non-conformances, resolving issues with relevant personnel
  • Provided QA approval for batch documents, log books, and batch reports

Quality Assurance Associate

Merck KGAA
Feltham
11.2019 - 09.2020
  • Managed customer complaints and investigation process
  • Compiled, tracked, and shared trend reports, proposing appropriate CAPAs
  • Prepared, updated, and reviewed Quality SOPs and Work Instructions
  • Supervised sample registers and ensured compliance with current artwork versions
  • Reviewed batch release documents from various EU sites to ensure compliance with UK regulations
  • Coordinated with various EU sites to ensure the documents were compliant and submitted them for UK QP release/certification
  • Ensured current GMP requirements for all areas were met
  • Assisted in preparation for inspection readiness

Production Officer

Lifepharma FZE
Jebel Ali
01.2018 - 02.2019
  • Supervised operational processes of oral solid dosage along with training of production personnel
  • Responsible for overall manufacturing process, manpower allocation, and planning of Batch Manufacturing
  • Conducted in-house calibration of equipment and maintained external calibration details
  • Part of the core investigation team from manufacturing
  • Reviewed documents generated in manufacturing
  • Audited overall manufacturing facility as part of GMP compliance team
  • Facilitated auditors and visitors in the manufacturing facility

Production Officer

Sance Pharma
Kerala
11.2015 - 12.2017
  • Shift in charge of manufacturing of Dry Powder Injection, Tablets, Capsules, Dry Syrups, and Sachets
  • Reviewed and approved Batch Manufacturing Records and reports generated from GMP equipment
  • Performed and reported in-process tests
  • Supervised and documented validations of autoclaves, vial washing and dehydrogenation units, and media filling studies

Education

Master of Pharmacy - Pharmaceutics

Mahatma Gandhi University School of Medical Education
Kerala
2015

Bachelor of Pharmacy - Pharmacy

Amrita Vishwa Vidyapeetam University Amrita School of Pharmacy
Kerala
2013

Skills

  • Quality Management Systems
  • Performing investigation
  • CAPA execution
  • Root Cause Analysis
  • Quality Records Management
  • Customer and Vendor Complaint Handling
  • Risk Assessment and Impact Assessment
  • Manufacturing Process Management
  • Operational Process Supervision
  • Equipment Calibration
  • In-Process Testing
  • Documentation & Compliance
  • Report Writing
  • GMP compliance auditing
  • Change Control Management
  • Documentation Review & Audit
  • Team collaboration
  • Planning
  • Training & Development
  • Inspection Readiness Preparation

Custom

Performing Investigation, CAPA Execution, Root Cause Analysis, Quality Records Management, Customer and Vendor Complaint Handling, Risk Assessment and Impact Assessment, Operational Process Supervision, Equipment Calibration, In-Process Testing, Report Writing, GMP Compliance Auditing, Change Control Management, Documentation Review & Audit, Planning, Training & Development, Inspection Readiness Preparation

Timeline

Technical Investigator

Lonza Biologics
01.2023 - 03.2025

Senior Quality Assurance Associate

Lonza Biologics
06.2022 - 12.2022

Quality Assurance Associate

Lonza Biologics
10.2020 - 05.2022

Quality Assurance Associate

Merck KGAA
11.2019 - 09.2020

Production Officer

Lifepharma FZE
01.2018 - 02.2019

Production Officer

Sance Pharma
11.2015 - 12.2017

Master of Pharmacy - Pharmaceutics

Mahatma Gandhi University School of Medical Education

Bachelor of Pharmacy - Pharmacy

Amrita Vishwa Vidyapeetam University Amrita School of Pharmacy

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