E. Musa Kyeba

Regulatory Affairs @ Pfizer

About

I have over 9 years of working in FDA regulated environments, with experience in Regulatory Affairs, Quality Assurance Quality Control, Environmental Monitoring, Validation, Aseptic Manufacturing, Supplier Quality, Device and Product Packaging Materials testing. I am currently a Regulatory Affairs professional responsible for maintaining registrations for existing products in compliance with applicable global regulations. I am also responsible for insuring all site change controls are appropriately assessed for local and global regulatory impact, acting as the site liaison with corporate regulatory affairs to plan and implement change controls and preparing site documentation in support of change controls. My previous position as a Quality Engineer Investigator required working closely and partnering with Manufacturing, Quality Assurance, Validation, Production, Chemical Quality and Maintenance departments on a daily basis to write and resolve Manufacturing and Quality Control deviations and implement Corrective and Preventive Actions. In addition, I have broad and in-depth knowledge of the various aspects of cGXP (GMP, GCP and GLP), FDA regulations and regulatory compliance.

Country

United States

City

Raleigh

Industry

Pharmaceuticals

Skill

Validation, Quality Assurance, Testing, Documentation, Analytical Chemistry, HPLC, Quality Control, Lean Manufacturing, 21 CFR Part 11, 21CFR 210, 21CFR part 211, Environmental Monitoring, Printed Package Materials Review, Clinical Trials, FDA regulations, Regulatory Affairs

Experience

Regulatory Affairs

Pfizer

2015-6 - Present · 11 yrs 4 mos

Raleigh-Durham, North Carolina Area

• Evaluates manufacturing changes for global regulatory impact and ensures compliance with applicable global regulations. This includes accurately describing the changes for ease of regulatory agency review. • Manages the preparation of registration packages and negotiates submission data requirements and deliverable dates with internal technical teams. • I am a member of a team that develops regulatory strategies for manufacturing improvements. Analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities. • Maintains awareness of regulatory legislation and assesses its impact on business practices in the manufacturing environment. • Reviews site procedures and policies for regulatory impact • Supports site GMP certification and license to manufacture activities. • Assesses site change controls for US and global regulatory impact.

Quality Engineer

Hospira

2012-8 - 2015-6 · 2 yrs 11 mos

Rocky Mount, North Carolina Area

Partners with Manufacturing, Chemical Quality, Maintenance and Technical Support departments to resolve deviations and production gaps Writes and completes investigations in a timely manner while utilizing practical problem solving tools Analyzes, understands and applies technical and scientific documents Ability to negotiate and influence others to achieve resolution Process improvement and product transfer projects Creates and or implements Corrective and Preventive Actions where applicable. Performs training of Investigators and Production personnel. Strong writing and verbal communication skills.

QC chemist

Novo Nordisk

2005-6 - 2012-8 · 7 yrs 3 mos

• Review and approve HPLC analysis data and documentation • Experience in printed packaging and device testing and inspection. • Create, review and revise standard operation procedures and course plans • Create and implement corrective and preventive actions where applicable. • Perform and prepare instrument qualification validation reports. • Perform assays via chromatographic methods and wet chemistry procedures. • Execution of operation (OQ), installation (IQ), and performance (PQ) qualification on lab instruments. • Perform training of QC/QA and production personnel. • Ensure timely investigation and closure of any out of specification and out of Trend investigations. • Lead lab cLEAN® Kaizen improvement tasks to facilitate efficiency in carrying out daily tasks.