Summary
Overview
Work History
Education
Skills
Timeline
Generic

Opeyemi Ogunyankin

Summary

Detail-oriented QA/Batch Record Reviewer with a proven track record of ensuring the highest standards of quality in pharmaceutical manufacturing. Adept at performing accurate reviews of batch records, collaborating with internal functions, and supporting real-time oversight to ensure compliance with Good Manufacturing Practices (cGMP).

Overview

7
7
years of professional experience

Work History

QA/Batch Record Reviewer

Lonza
05.2021 - Current
  • Streamlined the review process through the development of standardized templates and guidelines.
  • Manage and provide guidance to Quality Associates, ensuring direction during batch execution and reviewing GMP documentation.
  • Develop, direct, and maintain quality systems for CT/GT manufacturing, aligning with global quality systems, Lonza Corporate requirements, and regulatory standards (US FDA, European requirements).
  • Interface with site QA functions to support or develop interfaces with site-based QA systems, fostering working relationships with other site functions.
  • Oversee QA front-facing operations within the Viral Vector facility, including batch record review, on-the-floor QA support, MODA data review, and quality oversight for APSs.
  • Act as the first line of support for troubleshooting and build expertise in QA Ops teams, including staff development.
  • Apply aseptic manufacturing experience to ensure CT/GT operations meet customer and regulatory expectations for all phases of product development.
  • Reduced turnaround time for reviews by effectively prioritizing tasks and managing deadlines.
  • Enhanced team collaboration by regularly providing constructive feedback to fellow reviewers.
  • Supported continuous improvement initiatives by actively participating in team meetings, trainings, and workshops focused on enhancing reviewer skills and processes.

Quality Record Review Specialist

QuVa Pharma
02.2020 - 05.2021
  • Enhanced review accuracy by streamlining processes and implementing quality control measures.
  • Identified areas of improvement in operational workflows, leading to increased productivity and reduced errors.
  • Collaborated with cross-functional teams to improve overall review efficiency and effectiveness.
  • Managed a high volume of reviews within tight deadlines, ensuring timely completion and client satisfaction.
  • Perform timely and accurate review and completion of finished product and intermediate batch records to ensure adherence to quality standards and specifications prior to release.
  • Collaborate with internal functions to address all identified good documentation issues promptly.
  • Assure correctness and completeness of QA records, including Batch Records, Logbooks, and other relevant documents.
  • Work closely with Operations to promote awareness of Good Documentation Practices and Data Integrity.
  • Navigate through various systems such as Master Control, LMS, and INFOR to support the record review process.
  • Provide real-time oversight to the Manufacturing unit, ensuring products meet formulation, compounding, labeling, and packaging requirements as defined by SOP's and cGMP.
  • Support failure and discrepancy investigations, documenting process deviations or equipment malfunctions.
  • Contribute to the identification and implementation of appropriate corrective actions and preventive actions.
  • Provide QA support during aseptic processing and contribute to Environmental Monitoring within an aseptic environment.

QA Analyst

Alcon Manufacturing
06.2017 - 01.2020
  • Provide comprehensive support to QC, Analysis, and Test Service Team in conducting in-process and final product quality analyses/inspections, ensuring adherence to standards and regulatory requirements.
  • Tracks and documents incident and problem-solving actions and results through to completion.
  • Review and assist in the deviation review investigations.
  • Ensures all work is performed and documented in a timely manner and according to approved
    standard operating procedures and in general compliance with cGMPs.
  • Demonstrates a high level of discretion in the timely identification, and resolution of events
    potentially impacting the Quality of products and processes.
  • Participates in cleanroom product introduction activities.
  • Interpret and evaluate analyses for accuracy and precision, comparing results against established specifications.
  • Identify ongoing quality issues, proactively prevent potential production issues, and make valuable suggestions for improvement.
  • Utilize various measuring devices, testing equipment, predetermined methods, operations, setups, and prescribed specifications to accept or reject products.
  • Work from blueprints, diagrams, dial indicators, preset micrometers, scales, fixtures, customer specifications, drawings, or inspection instructions and checklists.
  • Support the laboratory team in daily microbiology laboratory operations, including organization/cleaning, routine equipment maintenance, supply inventory, and media growth promotion.

Education

Bachelor of Arts - Business Management

University of Ado-Ekiti
Ekiti State
09.2007

High School Diploma -

Holy Trinity Grammar School, Ondo, Ondo State
Ondo State
06.2001

Skills

  • Batch Record Review
  • Quality System Development
  • Compliance with SOP's and cGMP
  • System Navigation (Master Control, LIMS)
  • Aseptic Manufacturing
  • Documentation and Records Management
  • Audits and Inspections
  • Failure and Discrepancy Investigations
  • Corrective and Preventive Actions
  • Aseptic Processing Support
  • Environmental Monitoring

Timeline

QA/Batch Record Reviewer

Lonza
05.2021 - Current

Quality Record Review Specialist

QuVa Pharma
02.2020 - 05.2021

QA Analyst

Alcon Manufacturing
06.2017 - 01.2020

Bachelor of Arts - Business Management

University of Ado-Ekiti

High School Diploma -

Holy Trinity Grammar School, Ondo, Ondo State

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Opeyemi Ogunyankin