Quality Assurance Manager
LIPTIS EGYPT Pharmaceutical
Total years of experience :12 years, 9 Months
Review and approval of the Quality Manual.
•Review and approval of the Site Master File.
•Final approval of all SOPs to all technical departments.
•Final approval of Master processing and Packaging batch records.
•Review and approval of the Master Formula cards.
•Review and approval of Validation Master Plan, and Validation and Qualification protocols.
•Review and approval of Annual preventive maintenance plan and calibration plan.
•Review and Approval of auditing reports for both internal and external audits.
•Conduct supplier auditing on all raw and packaging materials supplier, and responsible for final evaluation of suppliers.
•Monitoring of the implementation of the calibration, preventive maintenance, and environmental monitoring programs.
•Final revision of the batch record and all related documents in order to decide the disposition for product release.
•Review and approval of product quality review report.
•Final Approval of raw materials, packaging materials, and finished product specifications.
•Review and approval of deviations, change control requests, complaints, Recall reports.
•Review and approval of Training plan, Matrix and forcing on implementation as per the scheduling.
•Review and approval of Self-inspection plan and forcing on implementation as per the scheduling.
•Member in management review board.
•Accomplishes quality assurance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.
•Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
•Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
•Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
•Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
Accomplishes quality assurance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.
•Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
•Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
•Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
•Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
•Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
•Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
•Successful pass of Libya ministry of health audit.
•Successful pass of Yemen ministry of health audit.
•Raw materials external suppliers lead auditor.
Lead the validation and Compliance team.
•Final approval for all validation and qualification protocol.
•Assist in internal audit inspections.
•Assist in external audit inspections.
•Review the internal/external audit report.
•Approve of Environmental quarter trend.
•Validation and qualification Training responsible for all departments.
•Review and approve the supplier qualification reports.
•Review and approve change requests and change action plans.
•Review and approve calibration certificates.
•Review and approve calibration plan.
•Prepare equipment/utility risk assessment to assign the required re-qualifications.
•Review the periodic product quality evaluation to assign the required re-validations.
Preparation of Process validation protocols (Solid)
•Monitoring all process validation runs.
•Preparation of cleaning validation protocols.
•Worst case selection study for cleaning validation.
•Calculate the acceptance limit for Cleaning validation.
•Preparation of Qualification protocols (mainly Performance qualification protocols.
•Review the Installation qualification protocols prepared by engineering department.
•Review the Operation qualification protocols prepared by concerned departments (QC, R&D & Production).
•Preparation of Facility qualification protocols (IQ & OQ).
•Review the utilities qualification protocols which prepared by Engineering department
•Implement all the qualification processes with their responsible.
•Creation of validation master plans
•Creation of HVAC & Water system performance qualification protocols
•Review the qualification documents of HVAC & Water system.
•Trends preparation for water station results.
•Trends preparation for Environmental monitoring results.
•Analytical method validation review.
•Engineering Sops review and approval.
•Responsible for Quality systems SOPs review.
•Responsible for Quality auditing (internal and external
Lead the validation and qualification team
•Final approval for all validation and qualification protocol
•Assist in internal audit inspections
•Assist in external audit inspections
• Preparation of Environmental quarter trend
•Validation and qualification Training responsible for all departments.
•Review the Validation Master Plan.
•FAT (Factory Acceptance Test) owner for the new machines.
FAT (Factory Acceptance Test) owner for the new packaging machine HOONG ã from south Korea
Preparation of Process validation protocols (Solid, Semi-solid & Liquid)
•Monitoring all process validation runs.
•Preparation of cleaning validation protocols.
•Worst case selection study for cleaning validation.
•Calculate the acceptance limit for Cleaning validation.
•Preparation of Qualification protocols (mainly Performance qualification protocols.
•Review the Installation qualification protocols prepared by engineering department.
•Review the Operation qualification protocols prepared by concerned departments (QC, R&D & Production).
•Preparation of Facility qualification protocols (IQ & OQ).
•Review the utilities qualification protocols which prepared by Engineering department
•Implement all the qualification processes with their responsible.
•Creation of validation master plans
•Creation of HVAC & Water system performance qualification protocols
•Review the qualification documents of HVAC & Water system.
•Trends preparation for water station results.
•Trends preparation for Environmental monitoring results.
•Analytical method validation review.
Review the registration files sent from
IPC team member & Internal auditor with the following responsibilities:
•cGMP implementation and monitoring the preparation steps in whole production (dispensing, solid, liquid, semisolid and packaging areas).
•cGMP implementation in warehouse.
•Toll out manufacturing monitoring.
•Inspection of water station performance.
•Export and registration responsible