Validation Engineer
Varichem Pharmaceuticals (Pvt) Ltd
Total years of experience :10 years, 11 Months
My role at this generic pharmaceutical manufacturer in Zimbabwe is to plan, develop, implement and monitor the company’s qualification strategy. I also conduct review of quality systems (including and not limited to equipment and utilities, root cause analysis, change control and risk management) and then communicate quality system principles that allow for more optimized solutions.
Ensuring timely, full and accurate posting of finished product to warehouse for all
production lines and manufacturing services.
Planning and scheduling workflow for each line operation according to established
manufacturing sequences, lead times and demand.
Workflow Optimization, compiling progress reports (KPI’s), and initiating actions on orders
and bottlenecks.
Daily yields tracking & Analysis (KPIs & KBIs)
Reporting out of Spec KPIs just in time.
Ensuring adherence to KORE, FSSC, EOSH, ISO and Schweppes company policies.
Stock management and reconciliation..
Supervising all involved site personnel and subcontractors.
Developing User Requirement Specifications for the assigned projects.
Design review and analysis of vendor design specifications (Design Qualification).
Installation Qualification, Operation Qualification and Performance Qualification.
Ensuring compliance to Occupational Safety, Health Environment and Quality Standards.
Monitoring work in progress and preparing weekly report of the status of each project.
Quality Verification and process control.
Quality Validation: Working with R& D in the development of specs for new innovations.
Sampling packaging material.
Ensuring consumer relative quality standards
Managing the resolution of supplier, departmental and process non-conformances using
SAP.
Upholding the SHE standards in the laboratory and in production
Generating Daily equipment availability reports.
Tracking and analyzing plant KPIs to reduce downtime.
Work order generation and release for weekly planned maintenance schedules using MMS
(COSWIN).
Managing equipment availability through planned preventive maintenance.
Coordinating and monitoring assigned engineering projects.
Contractor management (Supervising all involved site personnel and subcontractors)