Quality Assurance Manager

MONA ABDEL, B.D.S., M.S. 732-***-**** /

**********@*****.***

** **** ******, *********, ** 07086

CAREER SUMMARY

Knowledge of the drug development process, US FDA Regulations, INDs, NDAs

and ICH Good Clinical Practice Guidelines.

Detailed practical knowledge of test procedures in FDA regulated

environments, GxP, 21 CFR Part 11 regulations, Software Development Life

Cycle Management and working knowledge of Documentum.

Understands and applies the Drug Regulatory Terminology and purpose,

including informed consent process, IRB, Investigator and Sponsor

responsibilities.

QA/Validation/Test Lead experience working in the pharmaceutical industry.

Effective communication and presentation skills to provide training to

project team members.

Leadership skills, strong work ethic and focus on flexibility, ability to

multi-task, attention to detail, excellent communication, interpersonal and

organizational skills, good follow up and judgment, and able to prioritize.

PROFESSIONAL EXPERIENCE

Cardiovascular Research Foundation l New York NY 09/2013 - Present

Sr. Quality Assurance Associate

Acting as Head of Quality Assurance and representing the company as the

official correspondent.

Implementing and maintaining the quality program; promoting and

facilitating continuous improvement. Translating regulations, requirements

and guidelines into the company policy. Identifying and resolving quality

issues.

Performing internal and vendor audits according to the audit program, and

preparing audit reports.

Developing and implementing standard operating procedures (SOPs) for

quality assurance.

Ensuring compliance with Good Clinical Practice (GCP) and relevant

regulatory requirements. Acting as GCP expert consultant to employees

within the company.

Facilitating client/ sponsor audits and regulatory inspections: leading

tours, presenting requested documents and answering client questions.

Conducting training on regulatory requirements and quality initiatives.

Evaluating and ensuring closure of corrective and preventive action plans

(CAPA).

Conducting new hire orientation and training new employees, assigning SOPs

and training according to roles and job descriptions.

Managing SOP updates, distribution and maintaining the department intranet.

Working closely with various functional areas to facilitate adherence to

SOP and GCP training programs.

Supporting required system validation including software and databases,

conducted by internal staff or external consultants and providing guidance

as necessary.

Amicus Therapeutics l Cranbury NJ 04/2011 - 09/2013

Quality Assurance Specialist

Created and maintained software validation documents, and documented

validation activities supporting GxP system including User requirements,

pre and post executed test scripts, Design specifications, Traceability

matrix, Data migration plan, Risk assessment, Installation

Qualification/Operational Qualification/Performance Qualification,

Requirements specifications, Validation test plans, Validation summary

reports and Release to production statements.

Participated in workflow and lifecycle configuration, design of document &

contract management system software (NextDocs), software planning and

implementation meetings.

Determined the need of revalidation based upon changes to systems, and

performed revalidation under change control with proper documentation using

SysAid.

Created system templates, developed and designed pages that produce content

for the department Intranet (QA-GCP and GMP) via Intranet Dashboard (iD),

updated the site on a regular basis, and overall responsibility for the

content and functionality of the department website.

Prepared and presented NextDocs (SOPs, eTMF, and Contracts) and GCP

training to ensure all relevant team members are conducting studies in

compliance with the FDA regulations and guidelines, and provided

certifications to each trainee.

Developed, assessed, and audited QA Tracking logs and employee training

files. Provided periodic QC reviews of internal documents, maintained

updated CVs, job descriptions and training records. Created and submited a

quarterly report to the head of Quality Assurance and Compliance.

Developed and executed internal audit schedules, assessed compliance

practices and recommended corrective actions, managed and tracked internal

audits' corrective action plans, worked with CAPA owners, and ensured

appropriate correction actions are completed in a timely fashion.

Prepared and issued GCP audit certificates for audits conducted and found

to be satisfactory.

Created and reviewed Quality Assurance SOPs to comply with the regulatory

guidance.

Populated Excel databases for critical quality systems and dashboards for

quality metrics and management reports.

Communicated with the vendor and project team management on the status and

risks of the on-going test efforts and planned activities.

Provided subject matter expertise and technical support to NextDocs Modules

as needed (SOPs/eTMF/Contracts). Lead troubleshooting issues during the

test execution phases. Detected software failures and corrected them, and

maintained a database with software defects,

Appointed as a back-up for the QA documentation Manager (SOPs and eTMF),

and for the Contract Administration Manager.

Mentored the Contracts Administrator System Manager to ensure documents are

processed and approved appropriately according to the company procedures.

Drake College of Business l Elizabeth NJ 2009 - 2011

Dental Instructor

Taught Dental Assisting curricula courses including pre-clinical didactic,

and laboratory instructions.

Developed appropriate instructional materials and maintained required

supplies for assigned courses.

Used appropriate methods and materials to maintain curriculum objectives

for all subject matters.

Participated in collaboration with colleague instructors in building a team

approach to instructions.

Participated in departmental advisory committees and

activities/meetings/conferences.

Provided effective communication and organization skills in the assigned

teaching areas.

Private Dental Office l Marlboro NJ 2006 - 2009

Dental Assistant

Multi-Purpose Dental Clinic l Egypt

2003 - 2006

Dentist /Dentist Intern

Established and maintained extraordinary rapport with patients, by

thoroughly explaining dental procedures to decrease their anxiety.

Performed cavity preparations, placed Amalgam and Composite restorative

fillings.

Used dental instruments, x-rays and other diagnostic equipment, to diagnose

abnormalities, and plan appropriate treatments.

Diagnosed and treated gum conditions by scaling and root planning.

Designed and made Removable/ Fixed, Partial and Complete Prosthodontic

appliances.

Performed Root canal treatments and surgical extractions.

EDUCATION

Master's of Clinical Trials Sciences/Regulatory Affairs UMDNJ, Newark

NJ

BDS Dentistry

Tanta University School of Dental Medicine, Egypt

Relevant Academic Courses:

Regulatory Writing for Submissions and publications, International

Regulatory Affairs, Project Management, Regulatory and Ethical Requirements

in Clinical Investigations, Clinical Trials Overview: Methods and Practice,

Regulatory Requirements for Medical Devices, Adverse Event Reporting and

Postmarketing Activities, Food and Drug Law, Concepts of GXPs and Quality

Assurance, Multiple Analysis in Clinical Trials, Advertising and Labeling

in Pharmaceutical Medicine, Chemistry/Biochemistry, Botany, Zoology,

Physics, Statistics, Pathology, Microbiology, Pharmacology, Internal

Medicine, Operative Dentistry, Endodontics, Orthodontics, Dental

Prostheses, Diagnosis/ Radiology, Oral Pathology, Anatomy/Physiology,

Periodontics, Oral Embryology, Anesthesiology/Oral surgery, Dental

Materials/Lab, Pedodontics and Child Psychology.

DIA Courses: Overcoming Organizational Resistance to Portfolio Management,

Wrangling the Bestiary of Safety Documents, Communicating Drug Safety

Information, Quality Risk Management, Skin-drug Biotransformation, Auditing

Pharmaceutical Quality Systems, Advertising and Promotion, Innovations

Aimed at Improving Effectiveness and Speed of the Therapeutic Development

Process, The Role of CAPA in GCP/GLP Audit Quality Management Systems.

> Certification in Instructor Qualities in Adult Education,

Communication, and Public Relations.

> NBDE I: US National Dental Board; Microbiology, Biochemistry,

Anatomical Sciences, Anatomy & Histology.

> Bench Exam Preparation Course in Restorative Dentistry (UMDNJ)

> Certification in CPR/ First Aid/ AED.

> Certification in Investigator Obligations and GCP, Safety Management

in Clinical Trials, HIPAA and CITI.

> Certification in SCAW's IACUC.

PROFESSIONAL AFFILIATIONS

Drug Information Association (DIA).

Project Management Institute (PMI).

Steering Committee Member, NY BioPharma Networking Group (NYBPNG).

Member, North Jersey Affiliate of Susan G. Komen.

SKILLS

Language Abilities: Fluent in Arabic, learning Spanish.

Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Experience in Validation/ NextDocs/ SysAid/ SharePoint, Web-Design using

Intranet Dashboard (iD).

Contact this candidate