Adedayo Kukoyi.

Achievement

• Alongside the Director of Regulatory Affairs, we submitted an Abbreviated New Drug Application to the FDA in April 2023. I played a significant role in authoring & reviewing sections of Modules 1-3 of the eCTD.

Responsibilities

• Review and Approve Batch Records, Packaging records, and QC Certificate of Analysis for Media fills, Registration batches and routine manufacturing lots.
• Responsible for making final disposition for batch release.
• Provide QA oversight for sterile injection manufacturing under Aseptic Condition and Quality control testing of finished drug product
• Review and Approve process deviations and CAPAs resulting from Manufacturing.
• Execute and Provide oversight for Supplier/Vendor qualification (including contract testing laboratory).
• Lead Material Review Board Meetings and make final disposition on Deviations, Root Cause Analysis, OOS Investigations and Change Controls and process related investigations.
• Report Key Performance Indicators of batch disposition to the corporate leadership during Management Review meetings.
• Act as Subject Matter in establishment and execution of QMS activities such as Deviation Management, Change Control, Quality Risk Management, Product Complaints, Management Review, CAPAs, and Annual Product Quality Review.
• Review and Approve Analytical Method Development reports, Method Validation Protocols and Method Validation Reports as well as stability protocols and reports.
• Review and Approve Validation protocols (IQ/OQ/PQ) for all QC Laboratory Equipment, GMP Manufacturing Equipment, Utilities, Computer Systems as well as process validation.
• Provide guidance to Process Engineers/Research & Development Scientists in the deployment of ICH Q8, Q9 for Process Validation (Process Design, Process Performance Qualification & Continued Process Verification).
• Author & Review CMC Sections of ANDA specifically Module 3 (Quality section) by ensuring the content aligns with the pharmaceutical development report.
• Perform technical review of data compiled in the CMC section of eCTD Module 3 against source documents such as batch records, stability report, pharmaceutical development report etc.
• In conjunction with Quality Leadership, facilitate inspection readiness of the six systems (Laboratory System, Manufacturing System, Quality System, Material System, Facilities and Equipment System, Packaging and Labeling System) for Pre-Approval Inspection and Sterile Drug Inspection by conducting trainings and performing several mock audits.
• Represent the site alongside quality leadership during FDA inspection and other third-party audits.
• Establish and maintain the site Inspection Readiness Program

Achievement

• Alongside with the Research & Development Scientists and Manufacturing Engineers, we developed the design history file and Risk Management File for Thermo Fisher Scientific TaqPath COVID-19 Test Kit for detection of SARS-CoV-2 in samples containing Omicron Variant.

Responsibilities

• Act as site Risk Management expert for all process transfers, process optimization and new product development.
• Co-Lead Design history file creation for new invitro diagonistic testing devices by working closely with Manufacturing Engineers and R&D Scientist.
• Perform technical review of customer complaint investigation for Third-Party customers SCARs.
• Act as Subject Matter Expert on design review board to ensure design control was fully executed according to 21 CFR 820.
• Lead establishment of Risk Management Files for different product lines per ISO14971:2019.
• Ensure GMP activities aligns with expectation of ISO 13485.
• Provide technical support and training on investigation of OOS/OOT and manufacturing deviations.
• Support design transfer and new medical device development by utilizing design FMEA, process FMEA and hazard analysis to meet Risk Management requirement according to ISO 14971:2019.
• Support process analyst and production line leads on Six sigma projects to improve existing processes.
• Provide technical review and approval of qualifications, design validation, cleaning validation and process validations.

Achievement

• Alongside with the quality leadership we prepared the site for FDA Pre-approval Inspection for a New Drug Application and the site was able to obtain pre-approval based on I) Readiness for commercial manufacturing II) Conformance of our six-quality system to the CMC Section of the New Drug Application (NDA) and III) Satisfying agency requirement on Data Integrity

Responsibilities

• Support IQ/OQ/PQ and Process Validation Activities by reviewing executed protocols and reports.
• Facilitate cross-functional investigation to identify root cause for non-conformances reported during manufacturing.
• Facilitate and lead Material Review Board Meetings.
• Collaborate with Research & Development on method transfer from lab scale development to large scale manufacturing by conducting FMEAs and implementing results from DOE study.
• Co-ordinate Change Management activities for GMP Manufacturing Operations prior to start of manufacturing.
• Conduct periodic review of Non-conformances, CAPAs and report trends for Management Review.
• Utilize lean & Six Sigma methodology to perform continuous improvement to GMP Manufacturing Operation of Antibody Drug Conjugates by supporting manufacturing chemists with their blue belt projects.
• Collaborate with Director of Quality and other Quality Assurance SMEs to make the facility audit ready for GMP Audits (Internal & External).
  

Achievements

• Alongside the Head of Quality we made Swiss Pharma Nigeria Limited achieve WHO-prequalification for manufacturing and distribution of safe medicines in April 2014. (1st pharmaceutical company in West Africa to be WHO cGMP certified).
• Establishment of a robust procedure for Corrective & Preventive Actions (CAPA) that trends and analyzes all reported non-conformities from all GMP related activities in the company.
• Establishment of a Quality Risk Management operating procedure for FMEA, Risk Ranking & Filtering.
• Responsible for leading and providing oversight for over 50 Risk Management meetings, OOS Investigation, process deviation and change controls projects,

Responsibilities

• Conduct risk assessment for all process deviations, equipment failures, out of specification laboratory results, incidence, product development, equipment qualification and process/analytical validations.
• Carry out periodical follow-up activities on proposed CAPA plans and provide quarterly reports on effectiveness of the CAPA system to the management through the Quality Manager.
• Conduct and Co-ordinate cross functional investigation to identify root cause of any reported non-conformity from manufacturing processes, systems, facilities & utilities and other quality related activities.
• Compilation and review of standard operating procedures and protocols to be in line with current good manufacturing practice.
• Providing effective compliance inspection of all pharmaceutical production lines and processes and other support activities that have significant impact on product quality, patient safety, regulatory requirement and other validated systems.
• Lead and provide oversight for Change controls in all GMP Areas (Manufacturing, GMP Engineering, Packaging & Labeling, Quality control Laboratory, Material Management and Quality Systems).

Responsibilities

• Conduct and report on analytical method validation/verification for newly developed drugs.
• Chemical analysis of granules and compressed tablets withdrawn during process validation of new drug.
• Co-ordinate & report to head of research & development on execution of stability studies (accelerated, intermediate, long term) of raw materials, intermediate /bulk products and finished pharmaceutical products.
• Chemical analysis of bulk tablets & syrup manufactured according to approved test method.
• Chemical analysis of raw materials for manufacturing of drugs according to specified method in the US pharmacopeia or European Pharmacopeia.