Mukasa - Head – Quality Operations

Demonstrated experience with Regulatory Submissions.

Demonstrated experience with Quality Management Systems.

Demonstrated experience with Stakeholder Engagement.

Provide strategic leadership over Quality Control (QC), In-Process Quality Control (IPQC), and quality support functions to ensure continuous regulatory compliance.. Oversee batch documentation review, test result approval, deviation management, and final product disposition in line with NDA and cGMP requirements.. Actively support regulatory inspections, site licensing activities, and compliance audits by NDA and external partners.. Ensure effective implementation of SOPs, GMP controls, and documentation systems aligned with regulatory expectations.. Lead investigations into deviations, OOS/OOT results, and complaints, ensuring timely closure with effective CAPAs.. Coordinate qualification, calibration, and validation programs to maintain regulatory readiness.. Strengthen compliance culture through training, coaching, and continuous improvement initiatives.

Managed and maintained the site Quality Management System in compliance with NDA, WHO, and cGMP requirements.. Supported regulatory documentation including Site Master File, Quality Manual, Validation Master Plan, and SOPs.. Coordinated internal audits, regulatory inspections, and follow-up actions to ensure sustained compliance.. Oversaw batch record review, product release documentation, and regulatory reporting.. Led deviation, CAPA, change control, OOS/OOT, and product quality review processes.. Conducted risk assessments and ensured application of Quality Risk Management principles.

Supervised pharmaceutical manufacturing operations while ensuring full compliance with cGMP and NDA requirements.. Contributed to preparation and review of regulatory dossiers for NDA and WHO submissions.. Supported technology transfer projects and product site registrations for solid oral dosage forms.. Participated in regulatory audits, inspections, and compliance gap assessments.. Ensured effective documentation, in-process controls, equipment qualification, and cleaning validation.. Worked in a multi-country regulatory and operational environment supporting global product supply.

Supervised pharmaceutical manufacturing operations on the production shopfloor.. Conducted continuous professional trainings for interns, trainees and assistants.. Supported the execution of non-routine and routine validation studies.. Participated in qualification activities for equipment, computerized system.. Ensured effective documentation and in-process controls during batch manufacturing.. Attended multi-functional/ departmental trainings as part of succession planning.

Supported clinical pharmacy operations, pharmacovigilance activities, and medicine use evaluations.. Participated in ward rounds, prescription review, and stock management.. Assisted in preparation of clinical and regulatory-related reports.