NIBIN GEORGE
Portlaoise
Summary
Highly skilled Quality Assurance Specialist with a comprehensive understanding of QA methodologies in diverse industries. Possess strong analytical skills and the ability to identify risks and defects, ensuring compliance with quality standards. Demonstrated success in implementing effective QA strategies that have improved operational efficiency. Skilled at fostering positive relationships with team members and stakeholders to ensure project success.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist – Projects & Validation
Greenfield Global
Portlaoise
02.2024 - Current
- Company Overview: Excipient Manufacturing
- Managed Quality Management Systems (QMS): Oversaw critical QMS components, including Change Controls, Deviations, CAPAs, and batch documentation, ensuring compliance with GMP and regulatory standards.
- Developed and Executed Validation Plans: Designed and implemented validation strategies for manufacturing processes, equipment, cleaning procedures, and utilities, ensuring adherence to GMP and quality requirements.
- Prepared Comprehensive Validation Documentation: Authored and reviewed IQ/OQ/PQ protocols, validation reports, and qualification records, ensuring accuracy and compliance with regulatory standards.
- Collaborated with Production Teams: Provide comprehensive QA oversight for manufacturing operations including formulation, raw material handling, blending, and packaging.
- Managed Cleanroom Operations: Executed and oversaw cleaning of standard filler heads in ISO 8 cleanroom environments, maintaining stringent quality and hygiene standards.
- Resolved Non-Conformities and Quality Issues: Investigated and resolved deviations, OOS, OOT, and SCARS, implementing immediate actions and CAPAs to enhance process reliability and product quality.
- Led Change Control Processes: Managed change control for modifications to processes, equipment, and facilities, ensuring compliance and minimal disruption to operations.
- Qualified Suppliers and Third-Party Providers: Assessed and approved suppliers, contract manufacturers, and service providers, ensuring alignment with quality and regulatory standards.
- Supported Audits and Regulatory Compliance: Prepared for and participated in internal and external audits (HPRA, ISO, EXCIPACT), providing back-room support and ensuring adherence to quality standards.
- Conducted Risk Assessments: Identified, evaluated, and mitigated risks related to production, testing, and regulatory compliance, enhancing product safety and quality.
- Designed Process Strategies for New Product Introductions (NPI): Developed and implemented process scripts and strategies for NPI and continual improvement projects, aligning with project specifications.
- Implemented corrective actions for non-conformance issues in production processes.
QA Compliance Specialist
Thermofisher Scientific
Athlone
04.2021 - 11.2023
- Maintained Documentation Standards: Reviewed and maintained detailed records of manufacturing, testing, batch records, incoming material documents and regulatory submissions for transparency and traceability.
- Ensured Compliance in Manufacturing and Packaging: Oversaw manufacturing, packaging (ISO 15378), and distribution processes to ensure compliance with GMP and GDP standards.
- Mitigated risk by coordinating plans and specifications to maintain safety and compliance.
- Facilitated the investigation of compliance breaches and the implementation of disciplinary measures.
- Approved Batch Records and Product Release: Reviewed batch records, approved product releases, and ensured compliance with quality specifications and QP release criteria.
- Supported Inspection Readiness: Contributed to internal audit preparation and inspection readiness activities, ensuring regulatory compliance and audit success.
- Managed Incoming Materials Quality: Inspected and approved incoming packaging materials, ensuring compliance with quality specifications for production use.
- Conduct Acceptable Quality Limit (AQL) inspections, annual reserve sample inspections, and support investigations related to vials and syringes.
- Oversaw Product Label Compliance: Managed creation, verification, and approval of product labels, ensuring compliance with regulatory, marketing, and quality requirements.
Education
MSc - PHARMACEUTICAL BUSINESS AND TECHNOLOGY
Griffith College Dublin
Dublin, Ireland09.2020
BSc - RESPIRATORY CARE TECHNOLOGY
Rajiv Gandhi University of Health and Science
Bengaluru, India01.2017
Skills
- Quality Management System (QMS) oversight
- ISO 9001:2015
- ISO 13485
- Quality metrics & KPI monitoring
- Review and approval of deviations
- Product complaints
- CAPAs
- Change Control Process
- Quality Risk Assessment (QRM)
- GxP Standards
- Batch review and lot disposition
- Creation or Review and approval of validation protocols
- Cleaning validation
- Equipment Qualification (IQ/OQ/PQ)
- Process Qualification (PPQ)
- Review and approval of executed batch records
- Supporting internal audits
- Regulatory inspections
- Technical Writing
- Coordination with internal stakeholders
- Representing QA on cross-functional teams
- Use of analytical and judgment skills for problem resolution
- Ability to assess and choose viable, innovative options
- Effective Problem-solving
- Adaptability in Fast-paced Environments
Software Proficiency;
- 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)
Visa Status
Stamp 4 (No Sponsorship required)
References
References available upon request.
Timeline
Quality Assurance Specialist – Projects & Validation
Greenfield Global
02.2024 - Current
QA Compliance Specialist
Thermofisher Scientific
04.2021 - 11.2023
MSc - PHARMACEUTICAL BUSINESS AND TECHNOLOGY
Griffith College Dublin
BSc - RESPIRATORY CARE TECHNOLOGY
Rajiv Gandhi University of Health and Science
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