AMAL GALAL SOLIMAN

Muscat-Oman

Phone: +968-********; Email: ad03ds@r.postjobfree.com.

LinkedIn Profile: http://www.linkedin.com/in/amal-soliman-0a221129

PROFILE SUMMARY

+20 years of an extensive experience in Pharmaceutical QC/QA, GMP Auditing & Regulatory Affairs areas, supported with my [Post Graduate Diploma in QA/PRA] from Academy of Applied Pharmaceutical Sciences (AAPS) -Mississauga-0N, Canada

Professional Quality Compliance Auditor with full awareness of the Quality Management System and industry regulations, (cGMP) guidelines, ICH, Health Canada, FDA, EMEA requirements.

Dynamic and self-motivated pharmaceutical quality Expert with an excellent understanding of critical scientific review and evaluation of quality module of the submitted dossier from Regulatory body perspective.

Supported and coordinated all quality control activities within the QCL laboratory including analysis, reviewing testing of raw material, finished products for all dosage form samples.

Provided support in all kinds of investigations in case of OOS, complaints or/and audit enquires.

Professional in eCTD Compiling, Publishing, Tracking validation errors, Reviewing and lifecycle submissions through Lorenz DocuBridge & Extedo Software systems.

Completed Project Management, PM Infinity (preparatory course-36 hours)

Understanding of working in a multicultural environment with Strong interpersonal and communication skills

Demonstrated ability to prioritize work, adapt to change, meet objective / deadlines

AREAS OF EXPERTISE

Extensive knowledge of (QMS) and regulatory requirements

Quality Investigations, root cause analysis, and CAPA measures.

Reviewing & technical assessment of (CMC) of (API & FP) DMF and lifecycle submissions through Lorenz DocuBridge & Extedo Software systems from the Authority perspective.

Strong knowledge and understanding of the ICH,,Health Canada, FDA& EU guidance documents

Documentation management,

Audit reports & GMP Training program

Managing of CTD/ECTD training task.

Audit of finished products manufacturing sites & API Suppliers.

Categorization of auditing observation based on risk assessment.

Verifying data integrity.

Strong knowledge of Product application for proper Regulatory Submission.

Investigate all Product Technical Complaints

Monitoring of QCL Instrument’s

Calibration, qualification & SOP’s.

Periodic Product Reviews (PPR)

Experienced in reviewing stability reports

Strong communication, interpersonal and organizational skills.

Physical and Chemical Analysis.

Strong computer skills (word, excel & PowerPoint)

Strong computer skills (word, excel & PowerPoint.

KEY ACCOMPLISHMENTS

Successfully completed Post graduate Diploma in Pharma Quality Assurance/Regulatory Affairs 2020 from Academy of Applied Pharmaceutical Science- Mississauga, Ontario- Canada, including study of 21 comprehensive courses in both professions.

Conducted GMP External Auditing on API suppliers and finished products with focusing on high attention to details and based on risk assessment for more than 25 manufacturing sites in different countries to evaluate their compliance level with ICH, cGMP and current regulations in order to register these sites

Initiate OOS/CAPA investigations and ensures that CAPAs are tracked and implemented as committed within the scheduled time limit.

Conducted audit opening and closing meetings during the local and international inspection visits.

Issued, reviewed and approved of SOP’s and participated in issuing the quality manual.

Comprehensive, scientific and critical review and evaluation of submissions of more than 1000 DMF for different pharmaceutical dossiers, Natural health products & medical devices in order to approve the registration of such products in Oman or GCC countries.

Identified a critical, major and minor deficiencies in (M1-M3) while assessment of CTD/eCTD dossiers filed to Regulatory body.

Led a quality assurance team in all aspects in Central Laboratory of General Directorate of Pharmaceutical Affairs & Drug Control (DGPA & DC)-Ministry of Health –Oman in order to be an accredited & reference laboratory in Gulf Cooperation Council Countries (GCC).

Took an additional responsibility of leading ISO team and shared information / data with Quality Assurance Center to prepare for ISO 9001-2015 Certificate for DGPA & DC, MOH-Oman.

Successfully completed submissions to Health Canada Non Prescription and Natural Health Product Directorate (NNHPD) through e-post connect as a Trading Partner to submit new applications for filing of Natural Health Products (NHP).

Provided support to Medical Devices Importers in order to get approval of MDEL from Medical Devices Compliance and Establishment Licensing Unit Regulatory Operations and Enforcement Branch, Health Canada

Participated in organizing a QA/RA pharma conference in Cairo-Egypt for 2 years respectively 2017& 2018

Professional in eCTD Compiling, Publishing, Tracking validation errors, reviewing and lifecycle submissions through Lorenz DocuBridge Software system

Delivered training to a regulatory affairs staff on (eCTD) task through Lorenz DocuBridge Software coupled with e-Validator (OEM) [with a validation criteria of 1.4] for GCC area.

Provided technical, quality and compliance support as requested by the pharmaceutical regulatory staff at pharmaceutical industries.

Participated in issuing guideline of pharmaceutical drug master file submission though eCTD in order to implement registration of pharmaceutical products through eCTD a week before the assigned time.

PROFESSIONAL EXPERIENCE

Business Development Manager – PRA Consultancy – Marsh 2023 - Present

Regulatory Affairs Free-lancer- Ontario-Canada

Vetamina Healthcare Ltd, Burlington, ON-Canada, Nov.2019 – Nov.2020

Preparation of regulatory submissions for Natural Health Products (NHP) to NNHPD according to HC & FDA requirement.

Give precise attention to details in reviewing label of Generic products.

Ensures regulatory compliance with Health Canada requirements.

Communicate and follow up with Health Canada in order to fulfill a proper submission requirements.

Experienced with online RA guidance links.

Co-Founder &Technical Director

Pharma Biotec Solutions Consultancy, May, 2017- October-2018

Organized annual Pharma Regulatory Affairs/Quality Assurance Conference in Cairo-Egypt 2017 & 2018.

Compiling & Evaluation of CTD files.

Compiling of eCTD File through conversion of CTD file to eCTD file (including validation) by using our DocuBridge Lorenz software

Conducted a training workshops on CTD/eCTD DocuBridge Lorenz software.

Pre-Assessment visit for cGMP compliance

GMP Auditor and RA Senior Specialist

Ministry of Health, Oman, 2012-2016

Conducted cGMP auditing visits on different pharmaceutical manufacturing facilities, API manufacturers along with reviewing CAPA regarding all the audit previous observations against Saudi FDA guideline with a high attention to details in order to register those sites in Oman or for Central Registration in Gulf (GCC Registration).

Identified risks, proposed and implemented risk mitigation measures.

Follow up with the GMP Audit team to finalize and submit the GMP Audit final Report.

Support regulatory inspections and clients audits as per quality management needs.

Contributed to the monthly Quality Management Review (QMR) meeting and present relevant Quality topics as required

Reviewed and evaluate DMF those have been submitted for Products registration in Oman & other GCC Countries for accuracy and compliance with full attention to details using Extedo software.

Led Team on training and implementing eCTD project

Participated in issuing eCTD submission guideline for Health authority –Oman.

Reviewed and evaluated regulatory documents “Quality Modules [M1,M2 and M 3] and responses to deficiency letters by eCTD and through technical knowledge of pharmaceutical regulations

Provided regulatory support to external regulatory bodies through timely review of regulatory documentation

QC/QA Senior Specialist and GMP Compliance Auditor

Ministry of Health, Oman, 2004-2012

Participated in all Quality control laboratory QA/QC activities in order to get approval by GCC Technical Committee to let this lab. an accredited laboratory in Gulf area.

Participated in issuing, updating and reviewing of SOP’s and ensure congruence with good manufacturing practice (GMP) and quality manual.

Management and timely follow up of deviations, CAPAs, change controls and ensure that effective root cause analysis is conducted and that the CAPA process is implemented effectively.

Performed all kind of physical & chemical analysis for all pharmaceutical dosage forms using different types and models of HPLC, GC, UV, IR, KF, Balances, DT….etc.

Verified the implementation of GLP and Quality policy requirement

Conducted periodically self-auditing through pre-approved Q.A. check list

Trained newly hired quality staff.

QC Senior Analyst

GlaxoSmithKline, Egypt, 1995-2003

Trained Quality control laboratory staff at Cephalosporin area

Participated in laboratory system implementation: QCL Instruments, SOP’s, Calibration, annual demand and spare parts stock

Analyzed different pharmaceutical dosage forms by using different analytical techniques

EDUCATION AND PROFESSIONAL DEVELOPMENT

Post graduate Diploma in Quality Assurance/ Pharmaceutical Regulatory Affairs [QA/PRA] from Academy of Applied Pharmaceutical Sciences [AAPS]; Mississauga-ON, Canada

Preparing for the Certified Pharma GMP Professional Certificate from ASQ.

Project management at PM Infinity (35 Hours) (2017).

B.Sc. & M.Sc. (Biochemistry), Ain Shams University (Egypt)

N.BN.B.:

I Have a dual nationality (Egyptian/ Canadian Citizenship)

I have a valid Residency in Oman.

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