NIBIN GEORGE
Portlaoise,Ireland
Summary
A highly motivated Quality Assurance professional with 6 years’ experience in research, Pharmaceutical/Life science (QA Compliance, Operations, Validation and Projects), health care. A team player with a positive can-do attitude, experienced in working independently in fast-paced environments while dealing with employee relation and problem solving and change management scenarios. Committed to driving operational excellence and ensuring the highest standards of quality in all processes.
Overview
8
8
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work history
Quality Assurance Specialist
Greenfield Global
Portlaoise, Laois
02.2024 - 12.2025
- Authored/Part of Change Controls, Deviations/ Non-conformances and CAPAs, ensure scope and investigation of the record was clear and implementation activities were robust and timely.
- Provide QA support and oversight for a range of technical projects, including new product introduction (NPI), introduction of new equipment and new facility (Mixture unit, Blend tank and transfer line etc.)
- Authored/Reviewed/Approved/Executed of validation/Qualification documentations (IQ, OQ, PQ, SAT and summary reports) for new processes, equipment and facility.
- Prepare/Execution the validation protocols (Process validation, cleaning validation etc.).
- Work with Production department during aseptic manufacturing and filling in ISO 8 classified area.
- Execution and management of cleaning validation.
- Assess and qualify suppliers/ vendors to ensure their adherence to quality standards and regulatory requirements.
- Prepare for and participate in internal and external audits (HPRA, ISO, EXCIPACT, etc.) to ensure adherence to quality and regulatory standards and participating in back-room audit support.
- Risk Assessment - Identify, assess, and mitigate risks associated with the products, equipment, facility and safety.
- Prepare SOP, Batch trail/process validation training and support to staff to enhance performance and compliance.
- Performed product release for excipients.
- QA representative responsible for coordinating communication among all departments.
- Daily use of software’s – MS D365, Power Bi, Code soft.
QA Associate Compliance Specialist
Thermofisher Scientific
Athlone, Ireland
04.2021 - 11.2023
- Review/Approve Quality Agreements, detailed documentation of manufacturing and testing work instructions, Manufacturing/Production batch records, SOPs, Logbooks and regulatory submissions (COA or COC).
- Ensure that all secondary packaging (ISO 15378: Materials Used in Primary Pharmaceutical Packaging), and distribution processes comply with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Authored/Reviewed checklist for product release prior to the Qualified Person’s Release, and ensure quality compliance.
- Conduct internal audits.
- Conduct incoming inspection (receipt process) and release of incoming packaging materials, labels.
- Conduct Acceptable Quality Limit (AQL) inspections for secondary packaged finished products.
- Oversee the creation/verification/final approval of product labels, ensuring all regulatory, compliance, and marketing/customer requirements are fulfilled.
- Collect, analyses, and trend monthly and annual Site Quality Metrics using Veeva Vault ensuring compliance and initiating corrective actions as needed.
- Work in deviations/temperature excursions/product reject process.
- Train the new colleges about documentation review, Incoming inspection checks, Process checks and Documentation review.
- Daily use of software – Smart supplies, Veeva vault, Trackwise, Docusign.
Quality Assurance Officer
Sance Laboratories Pvt Ltd
, India
11.2017 - 04.2019
- Review/approver of new documents and document changes within QMS.
- Review and approve BMRs, MBRs, validation protocols and reports to ensure compliance with approved acceptance criteria
- Worked with production for aseptic manufacturing.
- Responsibilities for GMP, GLP, GDP requirements while performing manufacturing, Qualification and Validation activities.
- Autor and reviewer of SOPs and GMP docs.
- Management of Validation Master Plan (VAMP)
- Performed annual product review (APR).
- Performed risk assessment prior to each projects.
- Participation in continuous improvement programs to implement improvement in manufacturing, quality, safety and training system.
- Preparation, Pre- approval and review for- Product Quality Reviews(PQR), Batch Manufacturing Records(BMR)and Batch Packing Records(BPRs), Master Formula Records (MFR), Annual Product Reviews(APR) report and Annual Trend Sheet.
Respiratory Therapist (Internship)
Narayana Hrudayalaya Health institute
Bangalore
08.2017 - 04.2019
Education
MSc - PHARMACEUTICAL BUSINESS AND TECHNOLOGY
Griffith College Dublin
Ireland 09.2019 - 09.2020
BSc - RESPIRATORY CARE TECHNOLOGY
Rajiv Gandhi University of Health and Science
Bengaluru, India 09.2014 - 08.2017
Skills
- Veeva Vault, TrackWise, SmartSupplies, MS D365, Codesoft, MS Word, MS Excell, MS Teams
Certification
- Quality Engineer – Supplier Quality Evaluation & Management by Alison.
- ISO 9001: 2015 Quality Management System (QMS) certified by Alison.
- Internal and external audit training.
- Bioreactor Operations certified by National Institute for Bio processing Research and Training (nibrt).
Timeline
Quality Assurance Specialist
Greenfield Global
02.2024 - 12.2025
QA Associate Compliance Specialist
Thermofisher Scientific
04.2021 - 11.2023
MSc - PHARMACEUTICAL BUSINESS AND TECHNOLOGY
Griffith College Dublin
09.2019 - 09.2020
Quality Assurance Officer
Sance Laboratories Pvt Ltd
11.2017 - 04.2019
Respiratory Therapist (Internship)
Narayana Hrudayalaya Health institute
08.2017 - 04.2019
BSc - RESPIRATORY CARE TECHNOLOGY
Rajiv Gandhi University of Health and Science
09.2014 - 08.2017