Aws Erdisat
Validation Supervisor at MS PHARMA- Claim this Profile
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English Full professional proficiency
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Arabic Native or bilingual proficiency
Topline Score
Bio
Experience
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MS PHARMA
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Jordan
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Pharmaceutical Manufacturing
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700 & Above Employee
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Validation Supervisor
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Jun 2022 - Present
-Managing projects related to buildings innovations, new production lines, new machines, and qualifications projects (Start-up project for MS pharma KSA). - Take proactive initiatives and demonstrate a flexible approach to managing changing business needs and environments. - Conducting periodic meetings with team members regarding work priorities and ensuring work is progress smooth and inform team of company updates, departmental changes … etc. - Supervise the field work for… Show more -Managing projects related to buildings innovations, new production lines, new machines, and qualifications projects (Start-up project for MS pharma KSA). - Take proactive initiatives and demonstrate a flexible approach to managing changing business needs and environments. - Conducting periodic meetings with team members regarding work priorities and ensuring work is progress smooth and inform team of company updates, departmental changes … etc. - Supervise the field work for validation duties. - Organize all qualification, validation and Quality Documentation activities and prepare the required plans. - Follow up the validation work that performed by external agents. - Co-operate with related department(s) head(s) for planning schedule and implementation of validation works. - Preparing work schedule and allocating the daily work for validation and calibration staff. - Checking and reviewing the documents prepared by validation and calibration department. - Organizing all calibration & qualification activities and prepare the required plans. - Issuance of validation master plan. - Supervising the preparing of qualification documents for all production machines, laboratory instruments and utilities. - Reviewing and approving all documentation related for validation activities such as VMP, protocols, reports, etc. - Handling qualification & calibration of equipment, machines or instruments. - Handling process validation of new and existing products. - Handling cleaning validation and verification. - Handling monitoring schedule and its execution. - Handling software and computerized systems validation. - Handling thermal mapping for refrigerators, freezers, incubators, ovens, stability chambers & warehouses. - Handling qualification and evaluation of utilities.
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Senior Validation Engineer
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Aug 2020 - Jun 2022
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Pharma International Company
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Jordan
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Pharmaceutical Manufacturing
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700 & Above Employee
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Validation Engineer
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Apr 2018 - Aug 2020
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Philadelphia Pharmaceuticals
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Jordan
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Validation Engineer
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Jan 2017 - Apr 2018
1-Process Validation : -Prepare protocols , Select parameters, Monitoring the process , Calculations and prepare reports -Dealing with two types of process validation: A. Prospective process validation: for new products , changing manufacturing and change in batch size. B. Concurrent process validation: According to the requirements 2. Cleaning Validation : -Prepare protocols , select worst case product , calculation the limits , monitoring the cleaning , update the SOPs… Show more 1-Process Validation : -Prepare protocols , Select parameters, Monitoring the process , Calculations and prepare reports -Dealing with two types of process validation: A. Prospective process validation: for new products , changing manufacturing and change in batch size. B. Concurrent process validation: According to the requirements 2. Cleaning Validation : -Prepare protocols , select worst case product , calculation the limits , monitoring the cleaning , update the SOPs related , select cleaning hold time and Prepare reports . -The cleaning validation is a three types : A. Cleaning Validation : as a first time work the clean on line B. Cleaning Verification : after Several months of the cleaning validation as a same product on the cleaning validation. C. Cleaning Monitoring: after several months of cleaning validation on any product 3.Qualification : -Prepare protocols , select parameters , calculations and prepare reports -The Qualification is a four types : A. Design Qualification (DQ) B. Installation Qualification (IQ) C. Operation Qualification (OQ) D. Performance Qualification (PQ) and Re-qualification -Examples for Qualification : A. Engineering utilities and facilities :Heating, Ventilation And Air Conditioning (HVAC) System, Compressed Air system and WTU B. Plant Equipment's: Semi cartooning machine (CAM) , Filling machine ex. AFC machine , Preperation machine ex. Minoga and weghing booth (LAF) C. Thermal mapping for warehouse D. Laboratories :HPLC, UV, Laminar flow, stability rooms and Balances, etc.... 4.Calibration the instrument and utilities with external agent ex. Differential pressure gauges , Balances , Temperature sensors on machines , etc.... 5. Prepare the Validation master plan (VMP) , QPs , Layout and SOPs 6.Monitoring system for temperature and humidity inside chambers, incubators, refrigerators and stability rooms, etc Show less 1-Process Validation : -Prepare protocols , Select parameters, Monitoring the process , Calculations and prepare reports -Dealing with two types of process validation: A. Prospective process validation: for new products , changing manufacturing and change in batch size. B. Concurrent process validation: According to the requirements 2. Cleaning Validation : -Prepare protocols , select worst case product , calculation the limits , monitoring the cleaning , update the SOPs… Show more 1-Process Validation : -Prepare protocols , Select parameters, Monitoring the process , Calculations and prepare reports -Dealing with two types of process validation: A. Prospective process validation: for new products , changing manufacturing and change in batch size. B. Concurrent process validation: According to the requirements 2. Cleaning Validation : -Prepare protocols , select worst case product , calculation the limits , monitoring the cleaning , update the SOPs related , select cleaning hold time and Prepare reports . -The cleaning validation is a three types : A. Cleaning Validation : as a first time work the clean on line B. Cleaning Verification : after Several months of the cleaning validation as a same product on the cleaning validation. C. Cleaning Monitoring: after several months of cleaning validation on any product 3.Qualification : -Prepare protocols , select parameters , calculations and prepare reports -The Qualification is a four types : A. Design Qualification (DQ) B. Installation Qualification (IQ) C. Operation Qualification (OQ) D. Performance Qualification (PQ) and Re-qualification -Examples for Qualification : A. Engineering utilities and facilities :Heating, Ventilation And Air Conditioning (HVAC) System, Compressed Air system and WTU B. Plant Equipment's: Semi cartooning machine (CAM) , Filling machine ex. AFC machine , Preperation machine ex. Minoga and weghing booth (LAF) C. Thermal mapping for warehouse D. Laboratories :HPLC, UV, Laminar flow, stability rooms and Balances, etc.... 4.Calibration the instrument and utilities with external agent ex. Differential pressure gauges , Balances , Temperature sensors on machines , etc.... 5. Prepare the Validation master plan (VMP) , QPs , Layout and SOPs 6.Monitoring system for temperature and humidity inside chambers, incubators, refrigerators and stability rooms, etc Show less
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samra waste water treatment plant
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Zarqa Governorate, Jordan
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Trainer
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Jan 2016 - May 2016
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Education
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Tafila Technical University
Bachelor's degree, Chemical Engineering