AHMED MAGDY MOHAMED

Sterile manufacturing area in BFS techniques

· Validation and qualification department head in for the following :-

1. Update and develop annual general validation plan

2. Update and develop HVAC validation master plan

2.1HVAC validation protocol and reports

3. Initiate thermal validation of water for injection and purified water

inside water station (thermal sanitization)

4. Validation of building management system (BMS) project through

computer system validation 5.Qualification of machines and

equipment (URS, DQ, IQ, OQ and PQ)

6. Review Calibration Management plan

7. Preparing risk assessment mitigation plan

8. Review and update layout SOP

9. Update and develop process validation protocols and reports

10. Update and improve Media fill simulation protocol

10.1 media fill master batch record

11. Review master batch manufacturing records

12. Review MOC Recall Sop and simulation of Moc Recall trials.

12.Qualification of storage areas (Warehouse, cold stores, deep

freezer)

12.1 MKT calculation through the year of the warehouse.

13. Develop training plan for Validation QA team

14. Trainer for QA team for the following (media fill,

HVAC, Acceptance quality limit, compressed Gases)

15.Update And develop Acceptance Quality level

procedure

· Applied effective time management techniques to meet tight

deadlines.

· Used strong analytical and problem-solving skills to develop effective

solutions for challenging situations.

· Resolved problems, improved operations and provided exceptional

service.

· Review requirements, specifications and technical design documents

to provide timely and meaningful feedback

· Create detailed, comprehensive and well-structured test plans and

test cases

· Estimate, prioritize, plan and coordinate testing activities

· Design, develop and execute automation scripts using open source

tools

· Identify, record, document thoroughly and track bugs

· Develop and apply testing processes for new and existing products to

meet client needs

· Quality Assurance supervisor responsible for:_

· Start UP sterile local anesthesia manufacturing area.

· qualification and validation of sterile manufacturing area include the following :_

a. sterile pressure time filling machine (mark:Bosch)

b. fedegari autoclaves

c. HVAC system(testing and balancing, Qualification of AHU, Qualification of Rooms, Qualification of LAFs)

d. Compressed gases qualification

e. Water station qualification

f. Initiation of standard operating procedures

g. Thermal validation of preparation tank, storage tank

• Prepared and interpreted machine Qualification reports, complete with comprehensive analysis of testing and results, for development team.
• Assessed investigation reports of subordinate quality assurance personnel and addressed any procedural deviations.
• Monitored testing processes, test development and user acceptance testing.
• Used excell spread sheet to maintain database of test reports and calibration plan records.
• One of the team participating to obtain the manufacturing Regulatory license from EDA

• In process control tasks
• preparing IPC protocol
• preparing and update SOP for handling a deviation
• follow up media fill prepartion
• execution of HVAC validation tests according to ISO 14644
• review packaging batch records and processing batch records
• dispensing ipc checks
• Supported product managers and development teams across phases of testing from planning to execution, troubleshooting and reporting within high-volume, agile environment.
• Trained and guided onsite and offshore team members in quality assurance standards, policies and procedures.
• Checked configuration files and logs to uncover root causes of problems.

• Arranged appointments with doctors, pharmacists and medical teams to raise awareness of latest product launches.
• Analyzed market to identify new opportunities and strengthen relationships with hospitals, medical centers and primary provider physicians.
• Showcased product features to customers and discussed technical details to overcome objections and lock in sales.
• Conducted research to stay up-to-date with industry trends, prices and market competition.