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جمال ناصر الدين, Senior quality engineer and validation supervisor

جمال ناصر الدين

Senior quality engineer and validation supervisor ·Baxter international

الأردن

دبلوم عالي, Engineer

الخبرة العملية

مجموع سنوات الخبرة: 22 سنوات, 2 أشهر

Senior quality engineer and validation supervisor

أكتوبر 2014 - حتى الآن

Baxter international

الدمام، المملكة العربية السعودية

أكتوبر 2014 - حتى الآن

Part of my job responsibility's are:
1- Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
2- Close liaison with the building contractors, engineers and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols.
3- Prepare and execute the FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
4- Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.
5- Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
6- Maintain these relationships, monitoring KPIs so that performance and value for money is maintained.
7- Manage other validation team member(s), including their performance, development, training and compliance.
8- As a key member of the Quality team, contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders.
9- Key contributor in the project team to validate the manufacturing unit, working full-time on design, build and qualification activities.
10- Work effectively and supportively with other project team members to deliver the GMP manufacturing facility in accordance with the programe.
11- Draft and review GMP documentation including validation documentation, SOPs, and training documentation.
12- Train team members in procedures relating to validation as required.
14- Understand the production schedule, and work closely with Manufacturing and Engineering to build a qualification schedule.
15- Work in a safe manner, ensuring full compliance to HS&E policies.
16- Participate in and respond to external an internal audits

مجال الشركة:
صناعة الدواء
الدور الوظيفي:
مراقبة الجودة

Acting Manager Validation and Calibration Department

سبتمبر 2012 - حتى الآن

Dar Al Dawa Development & Investment Co

عمان، الأردن

سبتمبر 2012 - حتى الآن

My main work area is Pharmaceutical Validation, calibration, lab service and qualifications.

My ambition is to continually develop my skills as a person and technically on different techniques. Be proactive in my daily work and to practice continuous improvement in providing fast and good quality customer service. Keep high integrity to build strong and confidence customer relations.

Specialties
HPLC, UPLC, LC-MS, LC-MS/MS, GC, GC-MS, ICP, ICP-MS, FT-IR, NIR, AAS, Sun Systems, Validation (For labs shipments and manufacturing machinery), and all lab equipment used in pharmaceutical laboratories.

All includes complete system installation, Installation Qualification and Operation Qualification - DQ/IQ/OQ/PQ services. Preventative maintenance, trouble shooting, repairs and technical support.

مجال الشركة:
صناعة الدواء
الدور الوظيفي:
مراقبة الجودة

Validation Supervisor and lab service engineer

أغسطس 2010 - حتى الآن

Dar Al dawa Group

عمان، الأردن

أغسطس 2010 - حتى الآن

• Working with Chemical analyzers instruments (HPLC, GC, AAS, UV, UV-VIS, FT-IR, NIR, PH Meters, Ovens, Autoclaves, Stability Chambers, Incubators and DQ, IQ, OQ and PQ Qualification).
• I am responsible for the IQ, OQ and PQ for production lines, for Weighting Rooms, blending machines, blistering and capsuling machines, coating machines, granulating machines and packing machines.
• I am also responsible for the environment monitoring in plants, laboratories, stability areas and warehouses.
• Supervise, evaluate, develop, train and provide guidance to validation staff and provide timely and appropriate performance feedback.
• Assure that validation staff involved in validation activities are adequately trained on all applicable SOPs.
• Organize and plan validation schedules according to production planning.
• Write, review and approve validation protocols and final reports.
• Review and update validation master plans, as necessary.
• Provide Validation Manager with a list of validation projects completed during a specified reporting period and ensure that validation activities are performed in accordance to any regulatory guidelines or submissions.
• Assure full compliance with cGMP’s and other related requirements.
• Participate in Validation projects as required, including writing protocols, executing protocols, and writing final reports.
• Assist with development and monitoring of validation budget.
• Prepare periodic updates for upper management as to project status.
• Assist in auditing of internal and external processes, including serving as company representative during audits by various agencies.
• Make any task or having any responsibilities upon the direct manger orientations.

مجال الشركة:
صناعة الدواء
الدور الوظيفي:
مراقبة الجودة

Sales and service engineer

أكتوبر 2009 - يوليو 2010

Denise Est.

عمان، الأردن

أكتوبر 2009 - يوليو 2010

Service and installation, qualification and validation for analytical instruments

مجال الشركة:
الاستعانة بالمصادر الخارجية لخدمة العملاء
الدور الوظيفي:
خدمة العملاء ومركز الإتصال

Service Engineer

أغسطس 2007 - سبتمبر 2009

Hijaz Est

عمان، الأردن

أغسطس 2007 - سبتمبر 2009

Service and installation, qualification and validation for analytical instruments

مجال الشركة:
الاستعانة بالمصادر الخارجية لخدمة العملاء
الدور الوظيفي:
الهندسة

Training in The Technical Department

يوليو 2002 - أكتوبر 2005

Petra News Agency

الأردن

يوليو 2002 - أكتوبر 2005

Hardware/software operator

مجال الشركة:
الاتصالات والشبكات
الدور الوظيفي:
التدريس والشؤون الأكاديمية

Engener in The Technical Department

أكتوبر 2004 - يوليو 2005

Fx-net Network and Internet Provider

رومانيا

أكتوبر 2004 - يوليو 2005

Installing network and computer hardware and software configuration.

مجال الشركة:
الإنترنت والتجارة الإلكترونية
الدور الوظيفي:
الهندسة

التعليم

University "Gh. Asachi" - Iasi

فبراير 2007

فبراير 2007

دبلوم عالي، Engineer

رومانيا

Skills

Validation
Expert
Validation
Expert
Calibration
Expert
Calibration
Expert
Computer System Validation
Expert
Computer System Validation
Expert
Hardware 2FSoftware Installation
Expert
Hardware 2FSoftware Installation
Expert
Pc Software and Hardware
Expert
Pc Software and Hardware
Expert
IQ,OQ,PQ validation for chimical instruments
Expert
IQ,OQ,PQ validation for chimical instruments
Expert
Bio and medical instrument service and validation
Intermediate
Bio and medical instrument service and validation
Intermediate
Lab Equipment Maintenance
Expert
Lab Equipment Maintenance
Expert
Validation
Expert
Validation
Expert
CAPA Invistigation
Expert
CAPA Invistigation
Expert
GMP
Expert
GMP
Expert
Data Integrity
Intermediate
Data Integrity
Intermediate
Calibration
Expert
Calibration
Expert
Quality Assurance
Expert
Quality Assurance
Expert
ISO 1401
Intermediate
ISO 1401
Intermediate
Cleaning Validation
Intermediate
Cleaning Validation
Intermediate
Computer System Validation
Expert
Computer System Validation
Expert
GLP
Expert
GLP
Expert
Hardware 2FSoftware Installation
Expert
Hardware 2FSoftware Installation
Expert

اللغات

العربية
متمرّس
الانجليزية
متمرّس
الرومانية
متمرّس

العضويات

Jordan Engineering Association, www.jea.org.jo

Telecomunication Engineer

July 2007

Institute of Electrical & Electronics Engineering (IEEE),www.ieee.org

Electronic and telecomunication engineer

December 2006

Jordanian Romanian Forum for Culture, www.jrfc.go.ro.

President of JRFC

May 2009

التدريب و الشهادات

الشهادات
Computer System Validation Spicialest
Computer System Validation
Sep 2013 - Sep 2013
Mass Spectrometer Specialist
Mass Spectrometer Application
Apr 2011 - Apr 2011
Service Specialist
Installation and Service at LCQ Advantage MAX / XP MAX ( LC-MS, LC-MS/MS ) Instalation
Oct 2007 - Oct 2007
Fire Fighting and First Aid
Sep 2011 - Sep 2011
Service Specialist
Installation and Service for Accela (UPLC) and Surveyor (HPLC)
Mar 2008 - Mar 2008
Service Specialist
Waters HPLC
Jan 2011 - Jan 2011
Service Specialist
ChromQuest LC Qualification Traning for Surveyor HPLC and Accela UPLC
Mar 2008 - Mar 2008
Specialist in cGMP guidelines/trends in HVAC
cGMP Guidelines/Trends in HVAC Qualification/Validation for Pharmaceutical Sterile and Non-Sterile
Jun 2012 - Jun 2012
Tablet Tooling Specialist
Tablet Tooling Maintenance and Troubleshooting
May 2012 - May 2012
Tabletting Specialist
Tabletting Science
Oct 2010 - Oct 2010
Service Specialist
Thermo ICP-MS X Series II
May 2008 - May 2008
Service Specialist
ICP - iCAP 6000 series
May 2009 - May 2009