PETER OGUNDEKO
DANVILLE,IN
Summary
Detailed-oriented and highly motivated quality assurance specialist with a strong foundation in quality assurance processes and methodologies. Competent quality assurance specialist with several years of experience in oversight of product excellence. Proven record of quality leadership in all facets of production, team performance and fulfillment or delivery. Strategic in planning, implementing and improving processes and standards which generate opportunities for sustainable company growth.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
Millipore Sigma
Indianapolis, IN
2021.11 - Current
- Performed aseptic execution of assigned activities within the Grade A/B manufacturing area; activities include current Good Manufacturing Practices (cGMP) compliant gowning into a grade C and D environment
- Performs assessment of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
- Performs daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards
- Perform review and approval of executed documents
- Performs quarantine, segregation of material and line clearances
- Manages the CAPA and Change Control Systems
- Contributes to the continuous improvement initiatives
- Performs On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents
- Represents Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Trains and/or mentor employees, including provision of insights and education on processes and procedures, and conveying expectations of QA organization
- Reviews, and approves cGMP documentation including procedures, batch records (Bulk, Filling, Inspection and packaging records), validation protocols, development reports, specifications, and other related documents
- Reviews of COA, COC, and Quality documentation supporting shipment authorization of products manufactured
- Performs activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.)
- Reviews and approves investigations associated with products or processes
- Continually evaluating manufacturing processes and procedures with an eye toward continuous improvement
- Monitors manufacturing areas for compliance to SOP/cGMP/batch records and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time
- Initiates deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted
- Manages root cause investigations, close deviations, assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management
QA Team leader
Blue Marble
Indianapolis, IN
2019.01 - 2021.11
- Reviewed quality schedules to ensure the manufacturing of product(s) meet customer expectations
- Planned and reviewed quality systems, establishing priorities and sequences for manufacturing products and resolves operational, manufacturing, and maintenance problems to ensure minimum costs and prevent delays
- Assisted in review of data obtained during quality assurance activities to ensure consistency with company policies and procedures
- Assisted in developing new approaches to solve problems identified during quality assurance activities
- Assisted in informing management team of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation
- Utilized the appropriate personnel based on skill sets
- Evaluated, developed and ensured appropriate training processes are completed with Team Members
- Trained team members on production, quality and safety procedures associated with QA
- Ensured quality requirements and procedures for the area are understood and met
- Provided assistance to Team Members in solving problems/concerns that affect their performance
- Evaluate the issue and consult with Group Leader and/or Human Resources as needed to determine the most effective solution
- Analyzed data to evaluate the current process and process changes
- Assisted in the decision of accepting a product and/or continuing business with a vendor based on data collected
- Notified manager of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation
- Maintained a working knowledge of government and industry quality assurance codes and standards
- Other duties as assigned by the Quality Assurance Manager
QA/Production Audits
Performance Health
Indianapolis, IN
2017.06 - 2019.01
- Processed GxP training records to ensure training metrices are updated and accurate
- Supported client process audits for inbound and outbound shipments
- Supported internal training and compliance projects to include new-hire and recurring training for all associates
- Performed inspections and audits to ensure order accuracy
- Supported Management with Corrective and Preventative Actions (CAPA) program (TIP) to include performance of Root Cause Analysis
- Supported maintenance of calibration records, temperature control reports, and equipment for Performance Health and customer equipment
- Demonstrated active commitment to QSHE (Quality, Safety, Health and Environment) standards
QA Operations Specialist
Fidson Healthcare Plc
Lagos, Nigeria
2010.05 - 2016.12
- Undertaken general quality assurance audit of production processes (including but not limited to materials dispensing, product manufacturing, packaging, release and storage), personnel gowning and safety, production premises and good housekeeping, products and equipment in compliance with cGMP and Fidson Quality Policy to ensure production of consistently high-quality products
- Ensured that all observed incidents of on-line process violations, deviations and product quality complaints are reported, corrected and documented
- Generated routine QA compliance shift reports and communicated all non-compliant observations and the corrective actions taken in the reports
- Issued line clearance for manufacturing and packaging processes, having ascertained that all necessary GMP requirements have been met
- Ensured good housekeeping, personnel hygiene, appropriate gowning and environmental cleanliness are maintained on all production lines
- Undertaken final spot-check of finished products to ascertain that the final product quality is satisfactory prior to release and storage
- Ensured that major and critical non-conformities are promptly reported to the QA Manager for resolution and disposition
- Kept up to date/real-time records of in-process observations of production processes and product parameters
- Ensured that only duly calibrated and specified equipment are used for manufacturing and other related activities
- Enforced strict compliance with cGMP to ensure the manufacture and supply of good quality products
- Implemented withdrawal and retention of representative samples of packed products, from production lines
- Ensured all process control forms are accurately completed by production operators in real-time
- Any other jobs that may be assigned
Education
BSc. - Accounting
University of Lagos
01.2016
BSc. - Business Administration
Moshood Abiola Polytechnic
04.2010
Skills
- Warehouse Management Systems (WMS)
- TrackWise
- Root Cause Analysis (RCA)
- Data Integrity
- NuGenesis Scientific Data Management Systems (SDMS)
- Metasys
- Attention to details
- Analytical skills
- Problem-solving aptitude
- CGMP
- GDocP
- USP regulations
- Microsoft Outlook
- Effective Working Relationship
- Time Management
- Change Orders
- Change Controls
- Batch Documentation Review
- Cross-Functional Team leadership
- Continuous Process Improvement
- Quality Standards
Certification
Six Sigma Global Institute, Six Sigma Green Belt, In view
Process Improvement
- Trained with QA staff on best practices, resulting in a 35% improvement in team performance metrics.
- Applied a process optimization project that reduced batch record corrections timeline by 40%.
Timeline
Quality Assurance Specialist
Millipore Sigma
2021.11 - Current
QA Team leader
Blue Marble
2019.01 - 2021.11
QA/Production Audits
Performance Health
2017.06 - 2019.01
QA Operations Specialist
Fidson Healthcare Plc
2010.05 - 2016.12
BSc. - Accounting
University of Lagos
BSc. - Business Administration
Moshood Abiola Polytechnic