Engineering Quality Manager
Resume:
Cover Page
Dear Sir,
Over the last ** years I've gain experience and work in roles with increasing responsibility. I’ve developed, implemented and managed Metrology, Validation, and Preventative Maintenance programs with as many as 13 direct reports, managed multi-million dollar projects, and worked closely with Quality and Regulatory on submissions. I attend regulatory inspections with US FDA, Saudi FDA, Jordanian FDA, WHO and Europe (EU, Irish Medical Board, and UK). I understand cGMP and cGLP requirements and am familiar with PDA, USP, ICH, and HTM2010 guidance documents, and CFRs 210, 211, and Part 11.
I've work in Jordan & Saudi Arabia countries. I've managed aseptic, terminal, solid, semi solid, syrup and soft gelatin products manufacturing facilities validation programs. Best Regards
Ahmad Al-Fayoumy
RESUME for AHMAD AL-FAYOUMY
PERSONAL DATA
Permanent Address:
Amman-Jordan.
Nationality
Jordan
Mobile No.
adim6z@r.postjobfree.com
Place & Date of Birth:
Saudi Arabia. June 04, 1981
EDUCATIONAL BACKGROUND
High School Salah AL-Dean High School, Al-Ashraphia, Amman. Graduated July 1998 in the top ten percent of my class. Active at social programs. College Wadi AL-Seer Collage, Amman. Specialized in industrial electronics engineering for two years 1998 - 2000 at rate of 78.6%.
Philadelphia University, Technology Engineering Faculty, Amman-Jordan. 2005 with a B.S. degree in (Electromechanical) Mechatronics Engineering. GPA: 87.3% Merit Excellent. The first in my class and all Engineering streams. Advanced elective courses
PLC, Pneumatic & Hydraulic Drive, Instrumentation of process, DC & AC Motor rive, Electromechanical Systems Design, Process Control, Technical Writing & Power Electronic.
High-level language & Engineering Design Programs
Minitab, CADCAM &AutoCAD
Languages:
Arabic and English
Work Dimensions
Provide key validation input during ISO or GMP inspections.
Prepare, lead and manage audits and inspections, performed by different pharmaceutical organizations and regulatory agencies.
Ensure that Regulations requirements are being satisfied.
Develop quality system documents for validation, QC, Production, QA and manage implementation of programs.
Define and write standard operation procedures, Impact assessments, Risk assessments, Quality manuals, and ensure a continuous training of the production and laboratory personnel on the use, operation and validation studies of equipment and processes
Train employees on quality system documents for validation, QC, Production, QA & including the writing and execution of SOP’s, protocols and summary reports
Manage compliance of validation activities within other departments to meet established validation policies and procedures, GMP requirements and industry standards.
Report on any non-compliance with the implementation of the system and the proper documentation of the work.
Consult for new machinery specifications to conduct Installation, Operation, and Performance tests.
Prepare and participate actively in site audits and governmental inspections (ISO, SFDA, GCC, Health TGA, IMB, Swiss, France & Jordanian FDA)
Attend a continuous professional training program in different pharmaceutical fields (QA, QC, R&D, Validation, regulatory affairs, etc), in order to acquire a global vision of the pharmaceutical industry’s operations and to maintain, improve and broaden professional knowledge and skills
Design, plan, coordinate and manage validation projects in accordance with client’s needs
& requirements.
Interface with management, functional groups and different departments to facilitate prioritization and scheduling of validation work
Manage and implement the technical support statistical analysis to minimize the total downtime of the Manufacturing and Packaging machinery.
Conduct Equipment Qualification tests (Installation Qualification, Operational Qualification
& Performance Qualification), document and ensure proper filing of those documents.
Work on improving plants layouts and machinery specifications according to cGMP requirements with the supervision of Assistant Managing Director for Engineering.
Assess validation and revalidation requirements as part of change control system.
Maintain task list of validation activities, including responsible person, target completion date, current status and document number.
Manage annual revalidation schedules.
Aid in executing value improvement programs and aid process improvement initiatives through expert input.
Serve as project member or project leader on improvement programs as needed.
Train on all the systems of the department according to the requirements of the QA Department.
Train on all parameters of available machinery and equipment for documenting all related procedures.
Set-up and documentation of all the parameters needed for the systems (machinery, spare parts …etc.).
Train Engineering Department employees on the new systems and assure proper hand-over of systems.
Manage the control of environmental conditions at each plant room and compare to the recommended conditions specified by research and development and quality assurance departments.
Create compliance-related Environmental Health and Safety requirements; administer and provide training on associated Environmental Health and Safety programs.
Report environmental conditions and recommend corrective actions to be performed when environmental conditions are not satisfactory according to requirements.
Responsible of the maintenance and continuous improvement of the global cleaning validation program.
Ensure calibration is conducted on time, and fully documented. Weights, Speed Meters & Controllers, Tablet Press Speed Meters, Friability Testers, Dissolution Testers, Disintegration Testers, UV Meters, RTD Sensors& DMM.
Streamline and standardize cleaning validation program.
Build the site cleaning validation master plan and create and implement a computerized cleaning validation matrix, establishing worst-case equipment groupings in a multi-product environment
Develop and implement tools and innovative strategies to address projects with higher efficiency, thus exceeding pre-established business goals
Challenge, optimize and lean current processes to support operation business needs
Plan and coordinate cleaning validation projects in collaboration with business partners
(R&D, QA, QC, OPS), in order to meet production requirements, with respect to project constraints
Define and write cleaning validation protocols, train personnel, conduct trials and issue validation reports
Evaluate change controls and perform risk assessments to define the required process qualifications with respect to pharmaceutical regulations
Address production problems, identify deviations, lead investigations, determine, implement corrective actions
Lead and coach validation team members to achieve the desired business goals, while managing projects resources, timeframes and deliverables
Determine, review and approve validation deliverables for technical content and ensure adherence to site, corporate policies and procedures
Develop and implement the Validation Master Plan, which defines an overview of the validation activities, responsibilities and framework, structured in accordance with standard procedures
Qualify, ordering and validate the operations of a new analytical laboratory.
Coordinate validation activities in collaboration with other departments and external laboratories.
Write equipment and process validation reports, initiate and implement change controls and perform impact assessments
EMPLOYMENT EXPERIENCE
2000- 2002 Hikma Pharmaceutical, Wadi AL-Seer, Amman. Worked as Calibration Technician for two years.
Duties:
Conducting Calibration for monitoring devices and writing related SOP’s.
2002 -2005 Dar AL-Dawa Pharmaceutical, Na’ur, Amman, Working as Calibration Supervisor.
Duties:
Establishing Calibration Lab.,
Writing SOP’s for operating, testing, scheduling and systems.
Training & Supervising for calibration activities. 2005-2006 Dar AL-Dawa Pharmaceutical, Na’ur, Amman, Working as Validation & Calibration Section Head.
Duties:
Establishing machines Qualification programs
for semi solid, syrup, suppositories, solid dosage and sterile (eye drops, liquid ampoules) lines.
Training & Supervising for calibration activities. 2007 –March, 2012 Dar AL-Dawa Pharmaceutical, Na’ur, Amman, Working as Validation, Calibration & Environmental Control Manger. Duties: (Managing following programs)
Cleaning Validation program.
Media Fill.
QC instrument, Machine & Utilities
qualification (DQ, IQ, OQ and PQ).
HVAC and Utilities data trending and analysis.
Calibration of monitoring devices and QC
instruments
March, 2012 until Tabuk Pharmaceutical, Second Industrial City, Dammam, November 2017 KSA, Working as Validation & Calibration Manger. Duties: (Managing following programs)
Machine ordering (URS).
Conceptual design Review.
Cleaning Validation program.
Media fill (liquid Ampule, Liquid Vials and
Lyophilized Vials).
QC instrument, Machine & Utilities qualification
(DQ, IQ, OQ and PQ).
HVAC and Utilities data trending and analysis.
Calibration of monitoring devices and QC
instruments
Along with Establishing Validation and Calibration Systems.
March, 2018 until
December 2019 MS Pharmaceutical, Sahab, Amman, Jordan, Working as Validation & Quality Documentation Manger.
Duties: (Managing following programs)
Machine ordering (URS).
Conceptual design Review.
Cleaning Validation program.
Software Validation (according to GAMP 5).
Process Validation (soft gelatin, semi solid, solid dosage form, suppositories, syrup, external solutions and oral drops).
QC instrument, Machine & Utilities qualification
(DQ, IQ, OQ and PQ).
HVAC and Utilities data trending and analysis.
Control Facilities mapping.
Manage and approval of documentation system.
Manage Change Control System.
Manage Artwork approval system.
Manage batch record Issuance.
Lead paperless project for documentation
management system, by applying QMEX, to control
and manage SOP’s, Change control, Deviation,
Batch record, CAPA and Artwork electronics
records according to 21 CFR part 11.
January, 2020 Tabuk Pharmaceutical, Second Industrial City, Dammam, until Now KSA, Working as Validation & Project Manager. Duties: (Managing following programs)
Machine ordering (URS).
Conceptual design Review.
Cleaning Validation program.
Media fill (liquid Ampule, Liquid Vials and
Lyophilized Vials).
QC instrument, Machine & Utilities qualification
(DQ, IQ, OQ and PQ).
HVAC and Utilities data trending and analysis.
Calibration of monitoring devices and QC
instruments
Along with Establishing Validation and Calibration Systems.
Attended Training
7, 2000 -10, 2000
Hikma pharmaceutical, I had attended a course in Standard Operating Procedure (SOP) and Good Manufacturing Practice
(GMPs).
One month from Technical Center for industrial and Scientific Service, 5/08/2000 Authorized Agent FESTO Pneumatic I had attended a course in Pneumatic System.
5/10/2000 - 26/10/2000 Jordan University Center for consultation, technical services and studies. I had attended a course in Industrial Electronic Parts.
10/02/2002 LAB SERVE, Amman. I had attended a course in Concepts of balances and in quality Management systems and preventive Maintenance of balances.
27/03/2002 to Modern Language Center. I had attended a course in American 12/05/2002 English.
1 week from Jordan Accreditation Unit I had attended a course in 25-05-2003
Accreditation & Technical Assessment Techniques & ISO-IEC 17025 implementation.
2/07/2004 to Philadelphia University, I had attended a course in dealing 30-08/2004
with PLC Siemens S7200 & S7300.
30-08-2004 DAR AL-DAWA, I had attended a course in Incident Assessment Systems.
19-21 June, 2005 Nation Energy Training Center, I had attended a course in Energy Conservation in Electrical Systems.
27-29 August, 2007 Mettler-Toledo CO. SWISS LAND Training Center, I had attended a course in balances minimum weight determination, balance operation, calibration either analytical laboratory equipment’s validation.
30 August, 2007 RETRONIC CO. SWISS LAND Training Center, I had attended a course in Hygrolog data logger networking, calibration, adjustment and operation.
5-6 November, 2007 USAID Agency, I had attended an intensive workshop in capture market share with lean manufacturing.
11-12 Feb 2008
Pharma Support Center, I had attended an intensive workshop in water system, WHO Guidance, GMP Requirements,
pharmacopoeias Requirements, regulatory requirements, overview of the design of the systems, in-depth
understanding of the operational difficulties, menace of Bio- films, understanding on how to be in a state-of-compliance & validation.
3-8 August 2008 Lives International CO. France Training Center, I had attended a course in Thermal Validation and heat distribution studies. 25
th
& 26
th
February JAMP Center, I had attended an intensive workshop in good 2009 manufacturing practices, registration models for US and EU, Risk Assessment, corrective action preventive action (CAPA), self inspection and self auditing, cGMP compliance for outsourced activities, Retrospective qualification, and cleaning validation- acceptance criteria determination.
30
th
June 2009 JAMP Center, I had attended an intensive workshop in good documentation practices, documents formatting and
structuring, GDP requirements in FDA and EU Guidelines, documents corrections and change control, validation documentation and documents in QA, documents in QC lab, documents storage and archiving.
12
th
& 13
th
November, RETRONIC CO. SWISS LAND Training Center, I had 2009 attended a course in Hydrology data logger networking, calibration, adjustment and operation.
14
th
November, 2009 Mettler-Toledo CO. SWISS LAND Training Center, I had attended a course in comparator balances accreditation according to ISO 17025 "Lab Accreditation".
9
th
-13
th
July 2012 American University of Beirut, I had attended the business management training program, which consisting of the following modules: developing and managing people, leadership, strategic analysis and planning, team building and
high performance teams & creative thinking.
17
th
- 28
th
January 2016 Eastern Province KSA/ Engineering Training Center, I had attended Project Management Training & Certification Program (PMP).
16
th
-18
th
May 2016 Agon Academy, I had attended Risk Assessment and Risk Management training.
07
th
- 08
th
February Compliance online, I had attended the A to Z’s of Microbial 2016 control, monitoring and validation of waters for pharmaceuticals, biologics, medicals devices, cosmetics, and personal care products.
21 -22 Feb. 2018 Naratec Academy, I had attended Risk Assessment and Risk Management training.
07 Aug. 2018 Business Technology Solution “BTS”, I had attended Data Integrity training.
28 -29, Aug. 2018 Agon Academy, I had attended Computerized System Software Validation training.
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