Mohammad Katou
MS Pharma Injectables Site Manager at MS PHARMA- Claim this Profile
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Bio
Credentials
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Certified Lean Six Sigma Black Belt
American Certification InstituteJul, 2022- Nov, 2024 -
Project Management Professional (PMP)
Project Management InstituteMar, 2022- Nov, 2024
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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MS Pharma Injectables Site Manager
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Jan 2019 - Present
Responsible for Injectables site operations and develop processes which maximize leadership, safety, quality and productivity with cooperation of MS PHARMA talented team
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Corporate Quality Manager
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Jul 2017 - Jan 2019
Quality Management• Responsible for continuous Quality improvement projects in all MSPHARMA Injectables sites in Jordan and turkey• Responsible for Quality Management agreements with third parties• Establish quality plans and follow up CAPA plans• Build quality talent and training plans for quality team•lead project for Electronic Quality Management system Implementation QMEX.•lead ERP computer system validation project • Qualification of outsourced suppliers for GMP activities or services• Quality Management review meeting reporting and follow ups action plans.• Participate in quality risk management team for quality and business aspects• Leading internal and external audits• Prepare action plans and reports for regulatory authorities• Harmonize and improve quality systems procedures in different sites Show less
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Product Manager
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Jul 2015 - Jul 2017
provide pharmaceutical industry solutions and lab instruments to pharmaceutical companies with state of art technologies from: THERMOFISHER PAI METTLER TOLEDO BUCHI provide pharmaceutical industry solutions and lab instruments to pharmaceutical companies with state of art technologies from: THERMOFISHER PAI METTLER TOLEDO BUCHI
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Julphar
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United Arab Emirates
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Manager
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Sep 2009 - May 2015
Responsible QA Manager for Biotechnology production plants: A-Recombinant Erythropoietin API plant -JVII B-Recombinant Human Insulin API Plant -JXI - Establishment and control of new quality management system for JXI compliance with ISO 9001, EuGMP, ICH and local MOH guidelines. - QA Staff management, training and development. - Apply company polices, vision and long term targets. - Manage and plan QA activities. - Quality Policy, Site Master File (SMF), (Validation Master Plan) VMP, (Manufacturing formula and methods) MFM, (Standard Operating Procedure) SOPs, (Standard Testing Methods) STM, Specifications review, approval, authorization and maintenance. - Handling Internal and external quality audits. - key performance evaluation and reporting - Familiarity with ISO 9001/14001, ICH, EMA, USFDA, MHRA and other quality guidelines and standards - Vendors and outsourced activities suppliers qualification. - Qualification and validation protocols review and approval. - Deviation management, investigations, (Corrective Actions preventive Actions) CAPA follow up and CAPA effectiveness evaluation. - Change control management. - Quality Risk Management approach implementation in all GMP and quality related functions. - Knowledge and hands on experience in biotechnology and biopharmaceutical processes such as fermentation of genetically modified microorganisms, protein recovery techniques, protein refolding techniques, protein purification techniques (chromatography, Tangential Flow Filtration, crystallization and lyophilization) -knowledge and hands on experience in utility systems design as per ISPE, ASME and ISO norms for water treatments, HAVC, clean rooms, process air and others Show less
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Alkindi Pharmaceutical Industries
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Sahab- Jordan
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QC Assistant Manager
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Aug 2007 - Aug 2009
- Quality control department work management and planning. - Product quality checks and release. - Others as described in previous Job title. - Quality control department work management and planning. - Product quality checks and release. - Others as described in previous Job title.
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Alknidi Pharmaceutical Industries
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Sahab - Jordan
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QC Microbiology Head
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Jan 2005 - Aug 2007
- cGMPs, GLPs, FDA, ISO and MHRA requirements, updates and compliance. - Establishment of Microbiology lab including facility instrument ordering, standard operating procedures and system. - Laboratory work management and planning. - Method of analysis and specification preparation for all related microbiological test methods for all raw materials, in process and finished products. - Participation in establishment of Al Kindi Quality system. - Participation and supervision of all Factory machines and utilities installation, operation and qualification. - Instrument Qualification (IQ, OQ and PQ protocols preparation and implementation) and other validation activities. - Clean room qualification according to ISO 14644, and environmental monitoring programs. - Water system validation and monitoring program. - Sterilization process validation for autoclaves, SIP for tanks and filling line. - Cleaning validation for preparation vessels and filling machines, CIP. - Process validation and development. - Stability requirements for products and other related studies. - Product quality checks and release. - Internal technical audit member. - Production activities knowledge and specialist in aseptic and sterile processes and validation e.g. Media fill (Aseptic Process Simulation). - Establishment of Quality Assurance and sterility assurance system and follow up controls. - User Requirement Specification Board member. - Pest Control Program follow up. - Safety and best work practice follow up. Show less
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Hikma Pharmaceuticals
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Microbiologist
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Jan 2002 - Dec 2004
- Sterility testing and it validation according to USP and EP. Methods. - Bacterial Endotoxin testing (LAL method) and its validation. - Microbial limit testing for raw material and finished products and its validation. - Water testing. - Environmental monitoring for clean rooms. - Sanitizer Anti-microbial efficiency test. - Antimicrobial preservative effectiveness test for finished products. - Bacterial identification and isolation. - Heparin Bioassay. - General microbiological techniques knowledge. - Monthly reports and trends preparation. - Participate with FDA compliance group for Hikma chemical plant USFDA preparation. Show less
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Marwan Medical Establishment
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Amman-Jordan
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Medical Sales Representative
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Jan 2001 - Dec 2001
-Marketing medical products & laboratory instruments. -Keep track of competition’s new products & adapt different selling techniques. -Prepare quotations & offers for customers & provide after sales support. -Marketing medical products & laboratory instruments. -Keep track of competition’s new products & adapt different selling techniques. -Prepare quotations & offers for customers & provide after sales support.
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Education
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1998 - 2002
Al-Hashemite University
Bachelor's degree, Biology
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