Summary
Overview
Work History
Education
Skills
Personal Information
Awards
References
Languages
Certification
Accomplishments
References
Timeline
Generic

Mereena Kurien

Lilburn,Georgia

Summary

Results-oriented, experienced professional with a strong background in Pharmaceutical Quality Assurance roles. Skilled in problem-solving and optimizing performance. Capable of managing projects and collaborating effectively with teams. Committed to continuous learning and staying current with industry trends to contribute to organizational success. Known for leveraging analytical thinking and creativity to solve problems and deliver high-impact solutions in fast-paced environments. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Manager, Quality System

Alimera Sciences, Inc
Alpharetta, Georgia
01.2022 - Current
  • Ensured compliance with regulatory requirements and industry standards.
  • Coached, mentored and trained team members in order to improve their job performance.
  • Developed and implemented strategies to increase customer satisfaction and loyalty.
  • Established processes to ensure efficient workflow throughout the organization.
  • Conducted regular meetings with staff to discuss progress and identify areas of improvement.
  • Facilitated team meetings and workshops to foster collaboration and share best practices.
  • Oversaw daily operations, maintaining efficiency and quality standards.
  • Established and monitored KPIs to evaluate performance and identify areas for improvement.
  • Coordinated cross-departmental projects to ensure timely and successful completion.
  • Managed risk by developing and implementing effective risk management strategies.
  • Veeva QMS Vault Owner and System Management. Updated and maintained the Quality Management System documentation to reflect current practices and regulatory changes.
  • Conducted external CMO, Supplier audits. Facilitated FDA, GDNA, Pharmacovigilance, MHRA audits.
  • Change Control, Deviation, CAPA management
  • QA batch release for US and EU batches for QP release
  • Product Complaint Handling- Resolved customer inquiries and product complaints requiring management-level escalation.

Sr. Quality Associate-Batch Release

Takeda Pharmaceuticals
03.2016 - 12.2021
  • Led QA team, and provide coaching, counselings, and on the job training as required to build capabilities and enable professional growth
  • Developed and implemented product disposition (release) procedures and inventory system
  • Reviewed electronic batch records for compliances and performed final release
  • Performed visual inspections of finished products.
  • Monitored testing procedures to meet established item specifications, standard test methods or protocols.
  • Identified root cause of product defects and implemented corrective actions to prevent recurrence.
  • Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
  • Conducted thorough inspections of incoming materials and finished products to ensure quality standards were met.
  • Facilitate release meetings, ensure monthly and quarterly commitments to stakeholders and customers are met
  • Drove product Investigation completion (TrackWise) and released documents for timely lot releases
  • Communicate release targets to manufacturing, compliance, and supply chain groups
  • Developed and validated test methods for final products, bulk, and raw materials
  • Reviewed and approved LIMS data
  • Wrote validation protocols and reports, change control owner
  • Select Achievements: Developed product disposition department and process and systems for new manufacturing facility at Takeda Social Circle GA in 2017 and obtained FDA approval
  • Certified QA final product Visual Inspector
  • Developed and implemented continuous improvement processes.

Quality Assurance Audit & Compliance Specialist

C.R Bard
09.2014 - 02.2016
  • Ensured training compliance and closing of audit action items in a timely manner
  • Provide monthly matrix to Senior Management
  • Ensured the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint to the final closure of the file
  • Reviewed and approved investigations performed by the manufacturing site and OEM suppliers
  • Evaluated complaints for determining MDR/Vigilance events and documented rationale for not filing MDRs
  • Facilitated external audit for qualification for ISO standards
  • Ensure a ready to inspect state.

R&D Scientist-Chemistry and Microbiology

Abbott/Hospira
09.1999 - 08.2014
  • Started as R&D technician developing HPLC, UV and Dissolution method for oral doses
  • Later moved to R&D Microbiology Department in 2003
  • Served as Primary R&D Microbiologist representative and Dept
  • Micro Core Subject Matter Expert in product development project teams (sterile Injections)
  • Developed/validated micro-test methods for manufacturing plants to release new products to the market and to remediate old methods
  • Managed product remediations, API vendor programs, global product expansions and test method transfers to oversees labs
  • Served as micro reviewer for product submissions from Hospira India, contract labs, Austin and Liscate, supporting new product development, marketed products, and alternate API vendor programs
  • Wrote CTD sections for FDA and global regulatory submissions in support of ANDA and grand-fathered product submissions
  • VPP site Safety Chair, Calibration coordinator, Mentor.

Education

Bachelor of Science in Biology (Molecular Concentration) -

University of Wisconsin-Parkside
05.1999

Skills

  • Ensuring the development of high-quality medical products
  • Implementing robust processes
  • Encouraging a quality culture focused on continuous improvement
  • Responsible for end-to-end quality management system
  • Achievement of Key Quality metrics
  • Hands-on experience with quality systems
  • Developed strategies to create and implement efficient systems and processes
  • In depth understanding of GxP standards, FDA, EMEA, MHRA, MAH
  • Proven leadership skills, Managing Operations and Efficiency
  • Building and developing high performance teams
  • Experience in developing and leading strategies for process optimization
  • Organize, plan, and lead quality related projects
  • Resolving quality issues and concerns in a timely manner
  • Cross-functional team management
  • Process Improvement

Personal Information

Title: Outcome-oriented pharmaceutical Quality Assurance Leader

Awards

  • Fix the foundation award for iron sucrose project
  • Outstanding contribution award for successful implementation of eLN (electronic laboratory notebook)
  • Award recognition for taking ownership for the Clayton Propofol R&D microbiological studies
  • Award for successful ANDA approval of Hospira Propofol injectable Emulsion

References

Available Upon Request

Languages

English
Full Professional
Malayalam
Native/ Bilingual

Certification

ASQ Certified Manager of Quality/ Organizational Excellence, recertification needed.

Accomplishments

Fix the foundation award for iron sucrose project

Outstanding contribution award for successful implementation of eLN (electronic laboratory notebook)

Award recognition for taking ownership for the Clayton Propofol R&D microbiological studies

Award for successful ANDA approval of Hospira Propofol Injectable Emulsion

References

References available upon request.

Timeline

Manager, Quality System

Alimera Sciences, Inc
01.2022 - Current

Sr. Quality Associate-Batch Release

Takeda Pharmaceuticals
03.2016 - 12.2021

Quality Assurance Audit & Compliance Specialist

C.R Bard
09.2014 - 02.2016

R&D Scientist-Chemistry and Microbiology

Abbott/Hospira
09.1999 - 08.2014

Bachelor of Science in Biology (Molecular Concentration) -

University of Wisconsin-Parkside

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