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Regulatory Affairs Production Manufacturing

Location:
Bronx, NY
Posted:
March 12, 2024

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Resume:

Dina Qader

Mahwah, NJ ***** ad4ap2@r.postjobfree.com

Goal-oriented professional with strong analytical thinking, focused on solving critical problems, dedication to meeting achievable goals within short period of time, hardworking and organized, quick learner with strong attention on the main issues, specializing in manufacturing, research and development of producing vaccines and diagnostic kits. I am looking for a regulatory affairs position and Auditing opportunities.

Experience:

Regulatory affaires graduate, obtained my Master degree in Regulatory from Northeastern university, Boston, MA 2016 (Online).

Prepared different assay papers related to the latest regulatory affairs topics.

Addressed and answered various critical questions asked from top professors in the scientific field.

Provided valuable feedbacks on team project assignment.

Collaborated and corresponded with group members to facilitate different regulatory issues.

Teacher 2003-2006 (Averroes Academy, Northbrook, IL

Teach social and Islamic studies classes.

Prepare lesson plans.

Organize curriculum presentations.

Conduct parent/teacher conferences.

Arrange a variety of social events for students.

Microbiologist 1995-2000, JOVA Jordanian Company/Amman. Jordan.

Developed, manufactured bacterial vaccines and diagnostic kits.

Supervised, coordinate the multiple production manufacturing processes.

Served as key member of validation and Auditing team.

Ensure manufacturing qualities meet GMP and GLP standards.

Prepare IQ and QC protocols and required documentations.

Produce ELISA kit for brucellosis and Salmonella.

Produce immunofluorescent antibody test.

Produce wright test.

Produce complement fixation kit test.

Produce chromosomal kit test.

Addressed team members issues at different levels in order to improve general work performance and morals.

Mentor and train new staff members and interns, giving lessons and supervising their work.

Worked with Professor. Nadia Ghazal (CEO of Naratech Pharmaceutical consultancy) in addition to my work in JOVAC company on developing a new gene therapy (1998-2000), Amman, Jordan.

Professor assistant at Al-Mustansiriya University/Science and Microbiology department, Baghdad, Iraq 1993-1995.

Conducting research and giving lessons in the lab for college/university students.

Preparing midterm and final tests.

Prepare study materiel for Professors.

Grading the tests and writing evaluations for each student.

Prepare research and technical reports.

Education:

Biological and Microbiological Science 1993/Bachelor of science/Al-Mustansiriya University, Baghdad, Iraq.

Regulatory Affaire essentials certificate spring 2009/University of California, Sandiago, CA.

Regulations and Regulatory Affairs for Drugs, Biologicals, and Medical Devices 2016/Master of science/Northeastern University, Boston, MA.

Skills:

Languages,

English, Arabic.

Computer,

Microsoft Office: Word, Excel, PowerPoint, Outlook.

Analytical thinking (Highly qualified).

Critical thinking (Highly qualified).

Problem solving, Team Building (Highly qualified).

Process improvement (Highly qualified).

References available upon request.



Contact this candidate