Operational Excellence (Lean Sigma) Expert
Glaxosmithkline
Total years of experience :18 years, 2 Months
Operational Excellence Expert
Support day-to-day deployment of the GSK Production System (GPS) and performance improvement activities at site. .
▪ Work with line managers to identify and agree the priorities for GPS deployment.
▪ Support continuous capability development of self and others, developed by the GPS Core team.
▪ Actively role model GPS skills and behaviors.
▪ Support GPS by adopting processes and creating standard performance reporting KPIs for the implementation and success of GPS across site.
▪ Ensure that the escalation mechanisms and decision principles are followed to manage project priority and resource conflicts.
▪ Support/ensure consistency of progress and deployment.
▪ Coach individuals and teams in a range of roles and at all levels to develop and sustain continuous improvement mindsets and behaviors.
▪ Provide expert advice on the GPS basics to the Site based on an in-depth understanding of GPS.
▪ Lead GPS activities beyond the capability of the Site Teams.
▪ Fully Support Site Strategy Deployment, including delivery of key projects to achieve the Site’s ambition.
▪ Embed Change Framework Methodology, Mindset and Behaviors.
Title: Supply network operation- Raw material planner.
From: 12-2011 Till: Now.
Duties included:
• Maintains SAP material master data and key supply data in line with the POSS and SLEA’s.
• Communicates material requirements plans to suppliers and resolves conflicts..
• Participates in developing and renewing supplier Site-level Execution Agreements (SLEA's) with MSM resources
• Measures & drives Continual Improvement (CI) via daily/weekly/monthly standard work processes (UPI analysis, dead stock reduction, TMFA, VSM).
• Identifies critical material supply constraints and develops gap analysis action plans to avoid production and service impacts
In Process Control:
Control all process critical variables during all phases of manufacturing of the sterile product including:-
Ampoules
Control the process of ampules manufacturing including both aseptic preparation and terminally sterilized products.
Control the personnel behaviors including gowning, pre preparation, preparation, filtration, monitoring of the filling and the accidental intrusion and evaluate its criticality.
Eye drops & lyophilized vial
Control all stages of pre preparation such as cleaning and sterilization of equipments primary packaging material.
Reviewing CIP and SIP of lyophilizer and monitoring of the lyophilization events.
Control the critical variables during the preparation and filling (filling volume, torque) also GMP compliance.
Responsible for achieving a representative sample for each product stage.
Process validation
Participate in conducting retrospective validation study for ampoules and eye drops.
Awareness with other types of the validation (cleaning validation and sterilization validation).
Production
Tablets (1/2006-12/2007)
2 years of experience in tablet dosage forms including:-
Formulation:-
Preparation of different products s, Including wet granulation and direct comparison technique.
Compression (Tabletting):-
Experience in more than one type of compression machine including Fette and manesty.
Complete awareness by IPC of tablet compression stage including (friability, hardness, disintegration, dissolution) tests.
Coating
Skills in film coat, sugar coat and delayed release (enteric coated tablets).
Capsules
One year experience in preparation, filling, stripping and packaging stages. For various products especially Beta lactam.
Dry powder for suspensions :
Experience in formulation using fluidizing bed dryer, filling and packaging processes.
And ensure the compliance with legal legislation and cGMP rules
*work in tablets manufacturing department for 18 months .
*aware by packaging machines
*aware by GMP and ISO requirement
*work in beta lactam ( capsule, dry syrup, tablet)
*working as assistant manger for department
*courses in c GMP and validation
*hard worker, leader, team worker
• Waste saving, increase the yield and decrease the variation in the output achieving 300 k EP hard saving per year "DMAIC approach" Six Sigma Project “Black Belt”
total quality management six sigma (orange belt) statistical quality control planning for top quality ISO 9000 series managing quality functions project management