Chemist
Resume:
Rami Abu-Mallouh
Arlington, TX 76006 ***********@*****.*** Cell: 817-***-****
Objective:
Apply my education and experience in the Chemistry and Pharmaceutical Industry as a specialist. My goal is to improve my abilities and enhance my qualifications by achieving the highest levels in my career field.
Professional Experience:
Working in Chiquita (fresh express)-Grand prairie TX in QA since jul,2011 up to now
Working in Aljazeera Pharmaceutical Company since Nov, 2008 until April 2010
Working in The Jordanian Pharmaceutical Manufacturing Company, (JPM) from July 2003 until Nov. 2008 in different positions as follow:
Position: Stability Analysis Supervisor
Quality Control Department
Key Responsibilities:
1. Follow up receival and storage of stability samples.
2. Carrying out by supervising, the performance of physical, chemical and microbiological testing on finished products, according to stability programs.
3. Assign analysts to carry out analysis of product as per stability program.
4. Carrying out additional testing and/or the evaluation requested by different regulatory authorities.
5. Carry out validation and verification of new analytical methods.
6. Reviewing stability reports and the evaluation of stability data obtained by referring to the specifications and product trend.
7. Following the lab requirements for chemicals, glass ware and spare parts.
8. Contribute in the monitoring of compliance within the lab.
9. Participating in updating of Q.C documents related to stability.
10. Assure proper storage for stability samples at different conditions.
11. Provide registration section with stability data required.
Position: Senior Analyst Stability
Quality Control Department
Key Responsibilities:
1. Sampling, inspection and testing of stability programmed batches according to approved specification and MOA.
2. Record all analysis result in logbook and daily report.
3. Monitoring of compliance with the requirement of GMP and GQCLP.
4. Assists in the supervision of trainees.
5. Preparing stability documents required by registration section for registration in different markets.
6. Participates in evaluation of a new testing method and carrying out the required validation.
7. Follow stability chambers storage condition to assure compliance with required / setted condition.
8. Withdrawing samples for stability monitoring from production department and logging these batches within the stability testing program.
Position: Analyst
Quality Control Department
Basic Function:
Basic functions included sampling, inspecting and testing of starting materials, packaging materials, intermediate, bulk products and finished products, according to approved standard operating procedures, specifications and method of analysis. Included was the monitoring of environmental conditions for GMP purposes.
Key Responsibilities:
1. Sampling and testing of starting and packaging materials according to approved standard operating procedures and method of analysis.
2. Monitoring and analyzing the stored starting materials to ensure that it's still complies with the required specifications.
3. Sampling and testing of all intermediate and bulk products as well as finished products according to approved procedures.
4. Analyzing samples of starting materials received from different suppliers for quality evaluation.
5. Monitoring and reanalyzing samples retained at room temperature for their shelf life to guarantee the stability.
6. Record all analysis results obtained in the corresponding logbook and daily report.
7. Monitoring of compliance with the requirements of GMP and Good Quality Control Laboratory Practice.
8. Prepares finished product and raw materials certificates of analysis.
9. Participates in verification and validation of new analytical methods of analysis.
10. Prepares Batch Manufacturing Record / Quality Control Department.
11. Participates in inspection, withdrawal and testing of finished product stability samples.
Others Duties and Responsibilities
1. Prepared instruments manual user guide, calibration, verification and maintenance of common laboratory instruments such as HPLC,UPLC, IR, TOC, UV spectrophotometer, dissolution, disintegration, melting point, polarometer, refractive index, TLC- chamber and PH meter.
2. Participated in preparation for FDA inspection and EU-GMP inspection.
3. In Process Controller.
4. Reanalysis of working standards.
Additional Professional Activities:
1. Good analytical background.
2. Good experience in dealing with laboratory instruments.
3. Good knowledge of columns (stationary phases), detectors and software.
4. Good knowledge in GMP, GCQLP and stability requirements and guidelines.
5. Have capability in identifying problems and propose solutions.
6. High sense of responsibility and time respect.
Additional Personal Skills:
1. Good planer and organizer.
2. High attention to details.
3. Strong interpersonal and communication skills.
4. Ability to lead, clarify as well as participate as team member.
5.
Training Courses
Attended the following workshops & courses
Pharmaceutical StabilityTesting according to ICH Guidelines, FDA, GMP. Amman, 19 July 2006, organized by Lab Serve / Henry Marroum & Sons, presented by Michael Holzwarth.
Stability Testing: Learn By Doing Training Course. Amman, 9–10 December 2007, organized by Prescription Pharma Support / Dr MAHMOUD AL-QAQ, presented by Dr. USFEYA MUAZZAM ( He is a QUALITY HEAD FOR GERMAN FDA , he is a part of the MHRA Committee , ICH Committee and also he is REGULATOR ).
Language
English: very good ( Passed ILTS )
French: Good command ( Passed DELF A1 )
Arabic: Fluent – Native Language
Computer Skills
General computer user.
ICDL certificate.
1. Word
2. Windows
3. Excel
4. Power Point
5. Access
6. IT
7. Internet search
Education
B.SC Degree in Chemistry 2003 Hashemite University/ Jordan-U.S Equivalence by International Academic Credential Evaluators,Inc.Denton-TX-USA
References
References and additional materials are available upon reque
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