Summary
Overview
Work History
Education
Skills
Additional Information
Timeline
Generic

Sabry Mohammed ALshazly

Sr QA Team Leader Batch Disposition
Cairo

Summary

Experienced Quality Assurance with a demonstrated history of working in the pharmaceutical industry. Skilled in Pharmaceutics, product release, Annual product review, IPC for manufacturing and packaging Internal Audit, Good Distribution Practice (GDP), Good storage practice GSP), GMP Audit, , (Qualification and Validation. ) Data integrity, process validation, cleaning validation, computer system validation, water system validation, Commission and Qualification, Dry heat sterilization and compressed air qualification, Qualification of autoclave and pure steam, HVAC qualification and thermal mapping, Quality risk management, CAPA, Deviation, study quality tools (1- control chart,2cause and effect diagram,3-pareto chart,4-scatter diagram,5-flow chart,6Hisogram7-check sheet)through Minitab program, prepare training program for subordinate

Overview

32
32
years of professional experience
7
7
years of post-secondary education

Work History

Sr QA Team Leader Batch Disposition

Spimaco KSA
Buradah
09.2016 - 04.2020
  • Built strong relationships with customers through positive attitude and attentive response.
  • Conducted training and mentored team members to promote productivity and commitment to friendly service.
  • Established open and professional relationships with team members to achieve quick resolutions for various issues.
  • Mentored and guided employees to foster proper completion of assigned duties.
  • Conducted training and mentored team members to promote productivity, accuracy, and commitment to friendly service.
  • Supervised team members to confirm compliance with set procedures and quality requirements.

· Review and preparation of batch documents for final release.

· Update Annual product Review record related to the batch information of the entire product manufactured.

QA Inspection Team Leader

Spimaco KSA
Buridah
01.2007 - 09.2016
  • Conducted training and mentored team members to promote productivity, accuracy, and commitment to friendly service.
  • Communicated KPIs outlined in annual plan to inform employees of expectations and deliverables.
  • Promoted high standerds through personal example to help each member understand expected behavious and standards.
  • Managed leave requests and absences and arranged covers to facilitate smooth flow of operations.
  • Held weekly team meetings to inform team members on company news and updates.
  • Supervised team members to confirm compliance with set procedures and quality requirements.

· To represent QA inspection in all validation and qualification studies of process and systems.

· To ensure proper application of company policies and Current Good Manufacturing Practice in production, non-production area, manufacturing and packaging operation of each product for hourly release of product.

· To ensure the periodic review of all the reference sample is accomplished as per the schedule.

· To train properly newly hired inspectors to meet them in meeting QS objectives.

· To provide technical assistance and training to sub ordinate to maximize their performance without additional cost and to update them with cGMP.

· Document and report to QA management any failures, GMP violations, unsafe conditions or unusual results or practices.

· To prepare periodic reports for its evaluation to make sure that all activities are in line with QS objectives and I was assigned delegated as QA inspection supervisor with additional responsibilities with quality Assurance manager for any unusual incident in production or ware house area.

· Discus all problem encountered with all concerned department and involved in all corrective actions taken.

· Reviews process validation, equipment qualifications and company SOPs

· Conducts and supports corrective and preventive action program.

· Investigates customer complaints regarding quality.

Responsible for handling , disposing of product complaints and

Senior QA Inspector

Spimaco KSA
Buridah
04.1993 - 12.2006
  • Communicated with production team members about quality issues.
  • Performed visual inspections and non-destructive tests where appropriate.
  • Evaluated components and final products against quality standards and manufacturing specifications.
  • Completed precise measurements using special tools.
  • Developed and implemented inspection processes to define criteria and quality control measures.
  • Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
  • Identified and documented quality discrepancies for management to develop resolutions.
  • Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.
  • Trained and mentored junior inspection staff and interns to apply best practices and comply with quality control guidelines and regulations.
  • Collaborated with production staff to establish and meet quality standards
  • Performed root cause analysis to identify and resolve defects, improving quality standards.
  • Inspected quality of products, taking note of functionality, appearance and other specifications.
  • Resolved customer complaints by investigating problems and developing solutions.
  • Inspected incoming and outgoing materials for accuracy and quality.
  • Monitored product quality at all stages of production process.

· Collection of all bulk samples and semi-finished product samples as per material sampling instruction for each product and all reference ,stability .samples during packaging operation

· To record all manufacturing and packaging order no in the QA LOGBOOK

QA SPECIALIST

EIPICO Egypt
10 th oh Ramadan city
12.1987 - 03.1993
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Monitored product standards and quality-control programs.
  • Addressed non-conformance issues, pausing production to correct errors.
  • Updated inspection journals and daily summary logs with quality-related data.
  • Implemented process improvements to increase productivity in quality assurance operations.
  • Fixed identified issues to improve workflows.
  • Created and collaborated in implementation and maintenance of customer complaint log.
  • Analyzed quality and performance data to support operational decision-making.
  • Performed standard first article inspections and random sampling inspections to verify adherence to customer standards.
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
  • Reviewed production processes and identified potential quality issues.
  • Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
  • Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
  • Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
  • Drafted technical documents such as deviation reports, testing protocol and trend analyses.
  • Conducted data review and followed standard practices to find solutions.
  • Developed and implemented procedures to meet product quality standards.
  • Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
  • Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
  • Recorded and organized test data for report generation and analysis.
  • Created testing protocols to be used across product lines.
  • Reported problems and concerns to management.
  • Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
  • Collected and analyzed data to measure effectiveness of quality control processes.
  • Assessed products or services to evaluate conformance with quality standards.
  • Inspected items and compared against standards to meet regulatory requirements.
  • Performed routine maintenance and calibration on testing equipment.

Education

Bachelor of Science - Special Chemistry

Faculty of Science
Tanta Univericity
10.1981 - 05.1985

MBA - Quality Manegement

PAASTMT,Productivity And Quality Institute
Alexandaria-Egypt
04.2008 - 04.2011

Skills

Performance improvement

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Additional Information

Occupational health & Safety internal auditing
TUV SAUDIA ARABIA
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Internal Quality Auditing (ISO9001:2008
TUV SAUDIA ARABIA
Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
GMP TRAINING COURSE
SPIMACO AL -QASSIUM PLANT
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• General Aseptic area course
SPIMACO AL -QASSIUM PLANT-KSA
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Safety BASIC AWARENESS TRAINING
SPIMACO AL -QASSIUM PLANT-KSA
Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• GDP qualification for time and temperature sensitive product
webinar by quality department
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Applying Quality Risk Management
· · Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
A N O T H E R S K I L L S
L A N G U A G E S
CO U R S E S
· Dealing with Out of specification (OOS) Results through webinar by
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
Products stability and its relation to storage condition
SPIMACO AL-QASSIUM PLANT.-KSA
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
Out-of-Specification (OOS) and Deviation
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
Data Integrity and Documentation practice
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
· People Behavior and Cross Contamination through webinar by quality department on 24 January
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Industrial waste water treatment
Water Technology Expert Academy
Nanotechnology for environmental applications
Water Technology Experts Academy
·
Formulation development for Generic pharmaceutical products
Know -How Academy
HPLC Basic info webinar
Pharma peaks on line course
Sterile Manufacturing System Course
Valor Egypt for training and consultaion

Timeline

Sr QA Team Leader Batch Disposition

Spimaco KSA
09.2016 - 04.2020

MBA - Quality Manegement

PAASTMT,Productivity And Quality Institute
04.2008 - 04.2011

QA Inspection Team Leader

Spimaco KSA
01.2007 - 09.2016

Senior QA Inspector

Spimaco KSA
04.1993 - 12.2006

QA SPECIALIST

EIPICO Egypt
12.1987 - 03.1993

Bachelor of Science - Special Chemistry

Faculty of Science
10.1981 - 05.1985
Sabry Mohammed ALshazlySr QA Team Leader Batch Disposition