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Ahmed Omar Owtedah

QA / QC / HSE / R&D (CSSGB, QMS Auditor) •

A skilled professional with experience in Quality Management, Quality Control, Quality Assurance, Environmental and HSE, seeking a challenging assignment with a reputable organization, and leverage technical and leadership skills to contribute to the quality function and maintain world-class quality standards in environmental work. Interested Domain:

Pharmaceuticals,FMCG,Chemicals,Petrochemicals,Mining,Minerals industries,Laboratories. Work Experience

02/2015 - Present Jeddah, KSA

QA/QC Manager

Al -Hurafi for Advanced Contracting Co.ltd.

Chemicals and Mining Industry

Electroplating Division.

Logistic Division.

Health, Safety & Environmental Dept.

01/2003 – 12/2014 Jeddah, KSA

Operational Quality Senior Supervisor

Saudi Arabian Japanese Pharmaceutical Industry

Pharmaceutical Industry

Quality Assurance Departement .

Quality Control Departement .

Research and Development Departement.

Validation Departement.

01/1996 – 12/2002 Jeddah, KSA

Quality Control senior Analyst

Pharmaceutical Solutions Industry

Pharmaceutical Industry

Packaging Material Section.

Raw Material Section.

Microbiology section.

Finished Good Section.

Stability Studies Section.

Education

12/1989 – 02/1995 Jeddah, KSA

Bachelor's in Science

King Abdul Aziz University

Major

Biochemistry

Certifications

QMS Auditor & Lead Auditor (ASQ-CQA),(

Jun,2010)

Capable People,IRCA

Green Belt in Six Sigma, ( Jun,2009)

Asian Institute of Quality Management

Areas of Interest

Quality Assurance Quality Control Research and Development Health, Safety & Environmental

Hygiene.

Skills & Competencies

Team Work

Problem Solving

Design Making

Time Management

MS Office

Knowledge and development

SFDA

ICH

WHO

Pharmacopoeia

ISO 9001

ISO 19011

ISO 17025

ASTM

ISO 18001

Professional Trainings

Problem Solving and Design Making.

Time Management.

Total Quality Management Practices.

Cleaning Validation in Regulated Industries.

Purified Water System in Parma & Food Industries.

Quality in Technology Selection.

Practical Experiences in BSC’s Implementing.

Excellence in Society Services.

Good Manufacturing Practice Advanced.

Pharmacy Micro (P.Q.C. / Sterility Testing).

ISO 9000: 2001.

Shimadzu HPLC 2010 System.

First Aid.

Technical Laboratory Training.

Personal Details

Nationality

Palestinian (Egyptian Document)

Iqama Status

Transferable (0.25 point)

Marital Status

Married

Place of Birth

Saudi Arabia

Languages

English Arabic

Professional working proficiency Native

adpis2@r.postjobfree.com

+966*********

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PROFESSIONAL EXPERIENCE

AL-HURAFI FOR ADVANCED CONTRACTING CO.LTD. – KSA, JEDDAH Designation Chronology:

Feb 2015 – Up to date : Operational Quality Manager OPERATIONAL QUALITY MANAGER

Design and implement programs to monitor, ensure availability, maintenance, calibration of equipment in the factory and accuracy of all analytical procedures

Develop action plans with Production, Engineering, and Maintenance to improve product specifications, analytical procedures and that sampling programs are appropriate and meet system capability and key consumer requirements.

Review all new product formulations, process techniques and packaging to ensure compliance to existing regulatory guidelines.

Develop, maintain and support a team of qualified QC specialist and technicians to deliver quality excellence and meet department and company objectives and provide opportunities for employees to develop new skills.

Develop, maintain, and implement quality assurance policies, standards, and procedures for the entire factory.

Conduct effective root cause analysis and implement corrective action and preventive action plans

Develop a Quality strategy to eliminate and reduce defect waste and customer issues and claims.

Following EHS guidelines in the analytical laboratory and on the entire facility.

Responsible for environmental services (Air Quality monitoring water, quality monitoring) Sampling, protocols, reports…..

Responsible and review for laboratory information management system (LIMS).

Monitor the production areas for compliance to approved systems and procedures and GMP requirements.

Monitor and analyze operating data from the manufacturing process using statistical tools, both proactively (statistical quality/process control) and reactively (troubleshooting).

Ensure compliance to the Occupational Safety and Health Administration (OSHA) Chemical Hygiene Plan and Proper Laboratory Safety Practices by involving all employees in an effective safety program; provide training, periodic review of hazards, and timely correction of hazardous situations.

INSTRUMENTS USED

AAS (Atomic absorption spectroscopy), ( GBC,Savant AA).

XRF (X-ray fluorescence), (Micropioneer, Thermo).

Hardness Tester (Fischerscope HM2000S), (Fischer).

Thickness Tester (microderm), (UPA Technology).

Automated Titration (SI Analytical, Metrohm).

Salt Spray test (CW Special Equipment,BGD 880)

Rectifiers, Refract meter, Sodium Chloride Refract meter.

Opacity & hiding Power meter, Gloss meter, pencil Harness Tester.

Solvent Resistance Abraser, Abrasion Tester Surface Roughness Tester, Colorimeter. SAUDI ARABIAN JAPANESE PHARMACEUTICAL COMPANY (SAJA) – KSA, JEDDAH Designation Chronology:

Jan 2003 – Dec 2014: Operational Quality Senior Supervisor OPERATIONAL QUALITY SENIOR SUPERVISOR

Responsible for supporting new product, new materials, and new supplier qualifications and audit, working with R&D, and Purchasing.

Perform calibration and maintenance of laboratory equipment.

Adhering to the OOS, OOT procedures and documenting investigations.

Maintain the Data record and entree in all QC related documents and files.

Review the BMR & BPR before releasing of bulk product and finished product.

Water Treatment unit Validation, initiation and all related (chemical & Microbial) testing.

Prepare Common Technical Document (CTD) hard quality control for Registration Files.

Compliance with all GMP, QMS and data integrity requirements, as well as regulatory expectations.

Check and approve Data logger, Manual and Automated calculation analysis sheet, logbooks, and …. .

Prepare and managed a Plan for monthly, weekly, daily quality department staff activities for QA/QC DEPT.

Manage the training system in Plant, Ensure that all SOPs are in place, updated & training has been conducted.

Perform the testing for raw materials RO purified water semi finished products finished product and stability samples.

Responsible for Change Control system (including regulatory change ensuring ongoing compliance to registered details).

Check, update and approve protocols, analysis report, APR, SOP’s, QSP's and…..as per related pharmaceutical regulations.

Implement and maintain document control system as per good documentation practice and ensured their easy accessibility.

Follow through certification system, maintained complete documentation, and carried out failure studies and NCR for products.

Develop and maintain quality plans, operating procedures, work instructions, guidelines, and checklists for QA/QC departments.

Development and maintenance of relevant Quality and Safety Management Systems according to ISO and various other certifications.

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Qualifications (DQ, IQ, OQ & PQ) for HVAC (Heating, Ventilation & air conditioning) with all related calculations, study and recommendations.

Perform line clearance checks and in-process control checks for manufacturing & packaging of oral solids, semi-solid, liquids & sterile dosage products according to approved SOP’s.

Prepare, follow, sample collection and check document’s of site validation program, Method validation, Transfer Method, Cleaning Validation, Hold time (SOP, Protocols, Method of Analysis, results,….).

Prepare technical protocols, reports, standard operating procedures and work instructions, environment, health and safety documentation for laboratory work, sought management approval for circulation and approval.

Guide the Quality Assurance management system throughout the Supply Chain - from raw materials through production processes to final products.

Design, implement and evaluate plant programs and procedures as they relate to product safety and quality, including consumer complaints, Corrective and Preventative Action (CAPA), internal audit and training.

Responsible for managing certifications, including the completion of process documentation, product specifications, process auditing, and reporting systems that clearly track the status of product conformance. PHARMACEUTICAL SOLUTION INDUSTRY (PSI)- KSA, JEDDAH Designation Chronology:

Jan 2001 – Nov 2002: Quality Senior Analyst (Chemist)

Jan 1996 - Dec 2000: Quality Analyst (Microbiologist) QUALITY CONTROL SENIOR ANALYST (CHEMIST)

Conduct chemical analysis using wet chemistry process and analytical instruments.

Preparation of all required reagents for testing.

Develop people, resources, and budgets necessary to perform the QC functions according to plan and to deliver sustainable high standards of operation

Plan and organize all laboratory activities along with schedulers and coordinators on daily basis.

Provide assistance in preparation of standard operating procedures, and kept them updated all the time.

Perform sampling of in-process bulk material & finished products according to SOP’s.

Track calibration schedule and ensure timely calibration of laboratory instruments and maintain records of calibration.

Carry out troubleshooting of laboratory instruments and methods so that the tests were complete in time without backlog.

Initiate prompt action in resolving problems in laboratory inspection reports, manufacturer’s inspection reports and follow CAPA.

Conduct analytical and physical tests as per sampling plan as per approved procedures and test specifications and maintained test reports and relevant documents.

INSTRUMENTS USED

UPLC (Ultra Performance Liquid Chromatography) (waters).

HPLC (High Performance Liquid Chromatography) (Waters, Agilent, Shimadzu).

GC/MS (Gas Chromatography) (PerkinElmer, Shimdzu).

AAS (Atomic absorption spectroscopy)( Shimadzu).

Automated Dissolution tester (Sotax, Erweka,Pharma test,…).

Monitor particulate levels (Indair).

Particle size analyzer (Malvern).

FTIR,NIR

KF (Colum metric, Volumetric) (Metler Toledo).

QUALITY CONTROL ANALYST (MICROBIOLOGIST)

Conduct all tests of raw materials, bulk, finished products, stability samples etc.) For the micro laboratory as per approved test procedures and issue test reports and review.

Conduct trend analysis by monitoring environmental and water test parameters, evaluate test results and submit reports.

Supervise waste control system, disposal of wastes, pest control services and maintenance of hygienic condition, pest control.

Kept track of calibration schedule of micro biological laboratory equipment and ensure timely calibration and maintenance of calibration records.

Prepare microbiological media, and conduct growth promotion tests, purity test, assay of antibiotic and LAL test as per laid down and approve procedures.

Check the condition of the laboratory instruments and ensure that they were in working order, arrange repair in case of any malfunctioning/ defect by contacting the supplier.

Monitor inventory of laboratory chemicals, personal protective equipment and other consumable items and ensured that they were adequately stocked by providing logistics support.

Ensure compliance of all Packaging Materials, Product with quality specifications, Safety and hygiene standards

Follow good laboratory practice, health safety environment policies for the laboratory and ensured compliance with use of personal protective equipment, safe handling and storage of hazardous chemicals.

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