GERALD ANYANWU
QUALITY MANAGER
Saskatoon,SK
Summary
Quality professional experienced in developing organization's quality strategy, procedures, and processes. Monitor quality performance from supply chain and throughout product development life cycle. Develop and sustain Quality Management System in accordance with applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement.
Overview
15
15
years of professional experience
1
1
Certification
Work History
QA /QC & PROCESS IMPROVEMENT MANAGER
EMZOR PHARMA INDUSTRIES
08.2020 - Current
- Established and coordinated QA/ QC program to reduce product failure , production down time and increased production target
- Implemented lean manufacturing principles to optimize workflows, eliminating bottlenecks and increasing efficiency.
- Established robust training programs for QA/QC personnel, fostering a culture of continuous improvement.
- Coordinated internal facility audits for Quality management system related audits to ensure Facility has an Audit ready status at all time
- conduct related out of specification results investigation, aimed at ensuring released products adhere to regulatory specifications and meet customer requirement
- Drafted and Developed Manufacturing Protocols derived from process assessments and from optimized manufacturing protocols
- Established a continuous review process of customer requirement and specification to ensure swift product release in line with approved specification and compliance to regulatory standard
- Implemented robust documentation processes in line with Good Documentation practices in line with regulatory standard for better monitoring of QA/QC activities, improving overall transparency.
- Improved product quality by implementing rigorous QA/QC in process related activities from starting raw material to warehousing and shipment.
- Arranged for Product quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
- Participated in SAT & FAT for Pre Ordered pilot and commercial manufacturing equipment
- Collaborated with cross-functional teams by providing needed technical and operational assistance to achieve organizational set targets and goals
- Conducted Self Inspection Audits and Prepared audit reports with recommendation with regards to appropriate CAPA Plan
- Enhanced customer satisfaction with consistent product testing and timely resolution of customer complaints and product quality feedback .
- Established and Coordinated with Input Material suppliers in developing In house specifications and standards.
- Led process improvements initiatives, resulting in increased productivity and reduced operational costs.
- Reduced production downtime by proactively identifying potential risks and implementing preventive measures.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Implemented and delivered periodic related GMP , GLP GDP, HACCP , QRM and other quality programs
- Fostered a culture of open communication among QA/QC team members, promoting knowledge sharing and best practice adoption across departments.
- Conducted risk assessments to identify and mitigate potential quality issues.
QUALITY ASSURANCE SPECIALIST
EMZOR PHARMA INDUSTRIES
05.2017 - 08.2020
- Coordinated Quality Assurance programs to ensure Input Materials, Intermediate and Finished Products released for use and sale comply meets all Quality standards
- Monitored Production Processes for In process Test to eliminate product failures
- Evaluate samples for in process testing using calibrated and Qualified Analytical testing Equipment e.g Bulk and Tapped Density Testers, Particle size Analyzers, Precision scale Moisture content Analyzers, water Activity Testers
- Documented and reported quality assurance outcomes, providing actionable insights for product development teams.
- Established release specifications for Intermediates and Finished Products
- Coordinated commissioning and Qualifications of Laboratory Equipment's in line with appropriate guidelines
- Generated and reviewed Equipment Qualifications and Analytical process Validation
- Coordinated with Laboratory team to Maintain awareness of guidelines as per relevant reference books
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Participated in Out of Trend, Out of Specification, CAPA, non-conformance, and complaint investigation processes
- Coordinated all aspect of Good Documentation Practice and Issuance of controlled documentation such as Manufacturing Documents, SOPs, and Cleaning Logs.
QUALITY CONTROL / QUALITY ASSURANCE ANALYST
EMZOR FOOD & BEVERAGES
06.2012 - 04.2017
- Implemented HACCP guidelines, which includes conducting hazard analysis, establish critical control points, and monitoring and verifying control measures
- Implemented quality control measures, conducted inspections and audits, and ensured compliance with quality standards, specifications, and internal procedures
- Coordinated implementation of GLP protocols e.g proper documentation, recording of data, sample handling, and laboratory safety to ensure accurate and reliable results
- Identified areas for enhancement, drive process optimizations, and implement best practices related to food safety and quality assurance
- Performed daily quality and food safety related decision making based on established procedures
- Ensured adherence to approved SOPs and compliance
- Adopted all the HACCP/QA program's instructions for daily monitoring & verification
- Ensured that GMPs and plant regulations are effectively applied, conduct plant audits
- Facilitated relevant Internal Trainings on Quality Management System, Good Documentation Practices , Food Quality Safety etc.
PROCESS CONTROL ANALYST
EMZOR PHARMA INDUSTRIES
04.2009 - 05.2012
- Drafted, interpreted, implemented and evaluated adequacy of quality assurance standards
- Oversaw all aspects of testing of incoming materials and products
- Coordinated manpower requirements for a department to achieve production output
- Foster a positive employee relations culture by treating all employees with respect, listening to their concerns, and providing a timely response where needed
- Develop, direct, manage, train, and motivate employees by communicating job expectations, appraising job results in line with company policy.
Education
Master Analytical & Separation Science -
University Of Manchester
Higher National Diploma Chemical Science -
Yaba College of Technology
Master of Science - Biotechnology Innovation & Regulatory Science
UNIVERSITY OF PURDUE
INDIANA USA08.2017
Skills
- Sound communication skills
- Knowledge of Manufacturing, Facility design in line with relevant regulatory standards
- Familiar with Quality Management Systems and ISO Standards
- Attention to details, Strong, Analytical and problem-solving skills
- Knowledge of continuous process improvement and optimization strategies
- Workflow Analysis & Defect tracking
- Lean manufacturing principles & Lean Six Sigma
- Change Control Management & Complaint Investigation
- Risk Analysis and Mitigation
Certification
- WHMIS 2015 Certification. Canadian Center for Occupational Health and Safety. SK.
- Intermediate First Aid, Level C CPR/AED Certification (Saskatchewan Council)
- Good Manufacturing Practices & Good Laboratory Practices In Inspection process (West African Health organization - Cape Verde Islands)
- Equipment System Verification / Qualification and Pharmaceutical Process Validation (Compliance & Validation Services Limited Amsterdam)
Accomplishments
- Lead the Manufacturing and Cleaning Validation Team at Emzor Food and Beverages
- Developed various Standard Operating Procedures at Emzor Pharma
- Lead a team responsible for identifying, reviewing, and optimizing all manufacturing process aimed at reducing manufacturing cost while maintaining quality standard
- Managed oversea supplier of raw and packaging raw materials
- Team Member during Set up of Emzor Pharma Pilot Scale and Research Lab.
- Accountable for daily manufacturing operations, process optimization, failure investigation and reprocessing out of specification intermediate products
Volunteer Experience
- KNIGHT OF ST COLUMBUS (#8215), 10/01/2023, Present, Distributed Provisions and food items to Saskatoon Food Bank and Homeless Shelters, Volunteered for Food Preparations at Events coordinated by Knight of St Columbus, Assisted with the Distribution of coats to schools, homeless shelters, Pregnancy Centers and First Nation Communities., Volunteered are assisted in getting the Halls ready and clean up for events booked at the Cathedral Hall
- SAMARITAN PLACE, Assisting residents to the Chapel on Sundays during Mass
References
Available upon request.
Languages
English
Full Professional
Timeline
QA /QC & PROCESS IMPROVEMENT MANAGER
EMZOR PHARMA INDUSTRIES
08.2020 - Current
QUALITY ASSURANCE SPECIALIST
EMZOR PHARMA INDUSTRIES
05.2017 - 08.2020
QUALITY CONTROL / QUALITY ASSURANCE ANALYST
EMZOR FOOD & BEVERAGES
06.2012 - 04.2017
PROCESS CONTROL ANALYST
EMZOR PHARMA INDUSTRIES
04.2009 - 05.2012
Master Analytical & Separation Science -
University Of Manchester
Higher National Diploma Chemical Science -
Yaba College of Technology
Master of Science - Biotechnology Innovation & Regulatory Science
UNIVERSITY OF PURDUE
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