Summary
Overview
Work History
Education
Skills
Accomplishments
References
Certification
Timeline
Generic

Jeena James

CityWest

Summary

Production Operative and QA Intern with proven expertise in CGMP Compliance and Quality Assurance. Spearheaded PQS implementation and continuous improvement initiatives, resulting in a 10% increase in operational efficiency. Demonstrates exceptional analytical abilities and interpersonal skills to ensure regulatory compliance and enhance production quality.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Production Operative

Jabil Healthcare
Bray
04.2024 - Current
  • Reviewed over 50 documents,including SOPs,batch records,and validation protocols,ensuring 100%compliance with regulatory standards and minimizing compliance risks.
  • Supported daily manufacturing operations by providing real-time,on-the-floor quality oversight across up to 5 production lines,ensuring adherence to GMP procedures and reducing operational delays by 20%
  • Collaborated with QA teams to resolve batch manufacturing queries,ensuring timely release of batches and enhancing cross-functional communication to support production timelines.
  • Calibrated production and inspection equipment with precision,verfying compliance with regulatory and operational standards,resulting in 100%accuracy of measurement tools and reducing downtime related to equipment failures by 15%.
  • Conducted area clearances and batch record reviews in real time,providing quality input that helped maintain 100% product integrity and reduced quality issues during batch release.
  • Assisted in development and implementing 10+ operational procedures and training materials for quality related systems,improving procedural adherence and employee understanding of quality standards.
  • participated actively in continuous improvement initiatives and submitted 10+ Kaizen card suggestions that led to enhanced compliance and a 10%increase in operational efficiency.

QA Intern

Immacule Life Science Pvt Ltd
Himachal
06.2018 - 06.2019
  • Led the implementation and ongoing maintenance of the Pharmaceutical Quality Systems(PQS),achieving 100% compliance with regulatory requirements and consistently passing internal audits without critical thinking.
  • Reviewed and updated over 50 SOPs,quality policies,and other compliance documents to align with current regulations and standards,ensuring documentation remained 100% up-to-date and relevant for all audits and inspections.
  • Coordinated and tracked CAPAs from inspection,monitoring each to timely resolution and contributing 15% improvement in CAPA closure times.
  • Facilitated Quality Risk Management(QRM) sessions to proactively identify and mitigate potential risks in the processes,reinforcing a risk-based approach to quality that reduced potential compliance issues by 30%
  • Coordinated and tracked CAPAs from inspections and customer audits, monitoring progress to timely resolution
  • Facilitated Quality Risk Management (QRM)sessions to identify and mitigate potential risks in processes, fostering a proactive approach to quality assurance
  • Participated in Lean Six Sigma initiatives to streamline document management workflows,contributing to a 10%increase in operational efficiency
  • Actively participated in audits,ensuring compliance with GMP,and contributing to a successful inspection by regulatory authorities

Education

MSc - Pharmaceutical Business and Technology

Griffith College
Dublin
01.2023

Bachelor of Science - Pharmacy

Kerala University of Health Sciences
Kerala,India
01.2018

Leaving Certificate Equivalent -

St. Little Teresa’s HSS
Kerala, India
01.2014

Skills

  • CGMP Compliance
  • Quality Assurance
  • Deviation Analysis
  • Root Cause Analysis
  • SOP Process Optimization
  • Document Analysis
  • Audit Readiness
  • Pharmaceutical Quality Assurance
  • Continuous Improvement Practices
  • Six Sigma Implementation
  • Kaizen
  • Expertise in MS Office Suite
  • SAP Proficiency
  • Interpersonal communication skills
  • Strong Organizational Skills
  • Problem-Solving Expertise

Accomplishments

  • Collaborated effectively with a team of 5 operators to meet production targets, contributing to a 5% increase in overall output during peak periods.
  • Participated in Lean Six Sigma initiatives to streamline document management workflows, contributing to a 10% increase in operational efficiency.
  • Actively participated in audits, ensuring 100% compliance with GMP, and contributing to a successful inspection by regulatory authorities.

References

References available upon request.

Certification

  • GMP and Quality Assurances (innoskills 2024)

Timeline

Production Operative

Jabil Healthcare
04.2024 - Current

QA Intern

Immacule Life Science Pvt Ltd
06.2018 - 06.2019

MSc - Pharmaceutical Business and Technology

Griffith College

Bachelor of Science - Pharmacy

Kerala University of Health Sciences

Leaving Certificate Equivalent -

St. Little Teresa’s HSS

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