GERALD ANYANWU
Saskatoon,SK
Summary
Dedicated Quality expert knowledgeable about best practices in field, especially effective leadership strategies to motivate employee performance and job satisfaction. Well-organized in approaching problems to investigate causes and determine optimal solutions. Detailed understanding of organizational and regulatory expectations to drive performance.
Overview
15
15
years of professional experience
1
1
Certification
Work History
QUALITY & PROCESS IMPROVEMENT SPECIALIST
BOLD GROWTH INC.
SASKATOON
09.2023 - 12.2023
- Make recommendations for process improvements and work with other departments to implement change
- Provide technical assistance to various departments and assist with identifying compliance and quality assurance requirements while fulfilling company objectives and production deadlines as directed
- Help create, review, and maintain Standard Operating Procedures
- Facilitate the development and implementation of new processes
- Led process improvement initiatives following Lean & Continuous Improvement methodologies.
PRODUCT RESEARCH & DEVELOPMENT SPECIALIST
EMZOR PHARMA INDUSTRIES
08.2020 - 04.2023
- Identified and developed Manuals, Protocols, standard Operating Procedures and Manufacturing procedures for all scientific and technical functions
- Participated and coordinated Experimental and research Studies
- Conducted Pilot formulations, trial studies and Lab scale productions
- Drafted and Developed Manufacturing Protocols from optimized manufacturing records
- Conducted Input Materials compatibility studies for products under development
- Coordinated Inspections and audited firms for Contract Manufacturing Organization
- Conducted SAT & FAT for Pre Ordered research and Manufacturing equipment
- Conducted Self Inspection Audits and Prepared audit reports with recommendation with regards to appropriate CAPA Plan
- Worked closely with cross functional units on New Projects and New product developments
- Reviewed Packaging Materials design for New and existing products
- Established and Coordinated with Input Material suppliers in developing In house specifications and standards.
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
- Enforce Current Good Manufacturing Practices across all unit operations
- 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
- 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
- Generated, reported, and reviewed results from online process control tests
- Coordinated with Laboratory team to Maintain awareness of guidelines as per relevant reference books
- 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 AND 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, conducting inspections and audits, and ensuring 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
- Maintained accurate and organized records, including batch records, quality control documents, inspection reports, and certifications
- 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.
PROCESS CONTROL ANALYST
EMZOR PHARMA INDUSTRIES
04.2009 - 05.2012
- Drafted, interpreted, implemented and evaluated adequacy of quality assurance standards and P
- 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 of Science - Analytical & Separation Science
University of Manchester
Manchester , United Kingdom12-2008
MSc. Biotechnology & Regulatory Science -
University of Purdue (USA)
Higher National Diploma Chemical Science -
Yaba College of Technology
Skills
- Sound communication skills with various levels of individuals within the organization
- Knowledge of Manufacturing Facility design in line with relevant regulatory standards
- Ability to interpret conceptual and Detailed Engineering designs for Manufacturing Facilities in line with relevant regulatory guidelines
- Sound Knowledge of Microsoft Office Suites and productivity improvement tools
- Familiar with Quality Management Systems and ISO Standards
- Knowledge of continuous process improvement and optimization strategies
- Attention to details, Strong, Analytical and problem solving skills
- Takes initiative in knowledge transfer, training, and documentation at various levels and across a diverse multicultural organization
- Coordinates Technology Transfers and scale-up activities to commercial production
- Seeks to provide solutions in addressing Unit Operation constraints
- Strong work ethics, adaptable to changes and flexible to shifting priorities and deadlines
- Value Stream Mapping
- Workflow Optimization
- Operational Excellence
- Training Employees
- Quality Management Systems
- Statistical Process Control
- Lean Manufacturing Principles
- Waste Reduction
- 5S Methodology
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)
- Principles of Tablet and Capsules Formulation -(European Continuing Education London UK)
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 Lab
- Accountable for daily manufacturing operations, process optimization, failure investigation and reprocessing out of specification intermediate products
Volunteer Experience
KNIGHT OF ST COLUMBUS (#8215), 10/2023, TO DATE, 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
References
Available upon request.
Timeline
QUALITY & PROCESS IMPROVEMENT SPECIALIST
BOLD GROWTH INC.
09.2023 - 12.2023
PRODUCT RESEARCH & DEVELOPMENT SPECIALIST
EMZOR PHARMA INDUSTRIES
08.2020 - 04.2023
QUALITY ASSURANCE SPECIALIST
EMZOR PHARMA INDUSTRIES
05.2017 - 08.2020
QUALITY CONTROL / QUALITY ASSURANCE ANALYST
EMZOR FOOD AND BEVERAGES
06.2012 - 04.2017
PROCESS CONTROL ANALYST
EMZOR PHARMA INDUSTRIES
04.2009 - 05.2012
Master of Science - Analytical & Separation Science
University of Manchester
MSc. Biotechnology & Regulatory Science -
University of Purdue (USA)
Higher National Diploma Chemical Science -
Yaba College of Technology
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