David Mutugi Email & Phone Number

Nairobi County, Kenya

• Roles:
• Review of Site Master File and Validation Master Plan.
• Review of Standard Operating procedures.
• Monitored timely closeout of CAPA related to External audits and ensure its effectiveness.
• Participating in market complaint investigations.
• Promoting awareness of Quality and Regulatory compliance throughout the organization through organized training programs as and when required and participate in training of staff on quality systems to address.

Nairobi, Kenya

• Roles:
• Handled and coordinated the processing of change control, deviations, root cause and CAPAs to its full circle.
• Retrospective validation data collection, entry and compilation for preparation and trending of data for Annual Product Quality Reviews.
• Prepared quality assurance standard operating procedures (SOPs).
• Imparted SOP trainings and general topics in regards to cGMP compliance in the plant as scheduled on training calendar as per individual training needs identification matrix.
• Organized regular self-inspections/quality audits in coordination with the company pharmacist to appraise the effectiveness and applicability of the quality assurance system.

Nairobi, Kenya

• Roles:
• Gave line clearance to approve the start or continuation of each production process.
• Diligently discharged duties and responsibilities which included; online in process checks at production areas in tableting, oral liquids, dry powder filling, capsulation, creams and ointments departments.
• Product samples withdrawal for routine batches and submitted to quality control for analysis.
• Making periodic rounds in core processing areas and secondary areas for spot checks with an objective of identification of potential hazards if any and mostly check on compliance of cGMP in order for the products to.
• Verification of the dispensed raw and packaging materials.