Summary
Overview
Work History
Education
Skills
Languages
Affiliations
Accomplishments
Certification
Custom
References
Timeline
Generic

Mariam Mohammed Alyousef

Sayhat,KSA

Summary

A dedicated professional with extensive expertise in Quality Assurance and Auditing, leveraging strong problem-solving and communication skills to enhance operational efficiency. Proficient in ISO-9001 standards, CAPA processes, and root cause analysis techniques, ensuring compliance and continuous improvement. Skilled in risk assessment, FMEA, and value stream mapping, with a solid understanding of lean principles and 5s methodologies. Career goals include advancing quality management systems and driving excellence in organisational processes.

Overview

12
12
years of professional experience
5
5
years of post-secondary education
1
1
Certification

Work History

Qualified Person

Baxter Company Limited
Dammam, Eastern Province
01.2024 - 05.2025
  • Registered qualified person in SFDA.
  • Handled Exceptions, NCR/SNCR & CAPA of CQA issue.
  • Responsible for product complaints handling and usage of trackwise 8 program.
  • Evaluated new suppliers using a comprehensive scoring system to ensure compliance with company standards (supplier qualification lifecycle management).
  • Collect the information related to the batch documentation and perform the quality review for all routers and associate forms.
  • Addressed critical supplier issues promptly, enhancing overall operational efficiency.
  • Responsible for restricted areas control (quarantine, hold, return etc.)
  • Improved supplier quality performance by implementing rigorous audit processes.
  • Implementation of Quality of Systems related to Distribution.
  • Collaborated across departments for effective resolution of supplier-related issues.
  • Conducted detailed product inspections for enhanced production quality.
  • Monitoring temperature of distribution shipment.
  • Improved product quality by completing company, system and compliance audits.
  • Collaborated with engineering team to communicate and achieve quality standards and outputs.
  • Defined corrective actions for non-conforming products and complaints for continued quality improvements.
  • Updated relevant documentation, checking for accuracy and relevance.
  • Investigated customer complaints to address areas of improvement and eliminate non-conformances.
  • Worked on GME oracle-based program for release process.

QA In-Process Supervisor

Baxter Company Limited
01.2020 - 01.2024


  • Collaborated on cross-functional teams for comprehensive product evaluation.
  • Fostered a culture of continuous improvement within the team.
  • Identified potential issues through systematic risk assessments.
  • Reduced errors in production through detailed inspections.
  • Ensured compliance with industry regulations by implementing rigorous checks.
  • In-Process control activities, review of batch for product release.
  • Maintained up-to-date documentation, facilitating smoother audits.
  • Crafted and validated documentation outlining improved Standard Operating Procedures (SOPs) to drive continuous improvement.
  • Updated relevant documentation, checking for accuracy and relevance.
  • Responsible for handling and reviewing Controlled Events and in process quality control checks and to ensure all non-conformities are evaluated properly and that the associated corrective are executed properly.
  • Defined corrective actions for non-conforming products and complaints for continued quality improvements.
  • Adhering to cGMP and Quality Systems requirements.
  • Annual Line clearance challenge checks schedule preparation follow ups and review, review all production operator documents for certification and recertification of line clearance and visual inspection.
  • Responsible as backup for QP.

Production Release Team Leader

Dammam Pharma
01.2018 - 01.2020
  • SFDA registered responsible for quality.

  • Documented all release procedures for future reference and consistency in practices.
  • Final reviewer and approver of batch records of Dammam Pharma products for sale.
  • Led troubleshooting efforts for quick resolution of post-release issues.
  • Liaised with technical teams, ensured effective resolution of deployment issues.
  • Organised training sessions for staff members to improve understanding of new features post-release.
  • Analysed risk factors, minimised potential project delays.
  • Adhered strictly to compliance standards during all stages of the release cycle, upheld company's reputation and reliability.
  • Reviewed and update all QMS procedures in line with local regulatory and licensor requirements.
  • Evaluated the factors that may directly or indirectly affect the quality of product batch.

Plant Technical Manager

Montajat Veterinary Pharmaceuticals Co. LTD.
01.2016 - 01.2017
  • Periodic review of quality and cGMP compliance.
  • Involvement in SFDA audits.
  • Technical departments harmonizing.
  • Conduct weekly technical meetings and monthly quality meetings.
  • Ensured timely completion of projects through effective resource management.
  • Appraised and monitored technical staff performance to identify development opportunities and promote growth.
  • Produced technical schedules in line with production specifications.
  • Promoted best practices to uphold output quality standards.
  • Led conformance activity across environmental, health and safety and regulatory compliance.

Quality officer

Tabuk Pharmaceutical Manufacturing Co (TPMC)
Dammam
01.2013 - 01.2016


  • Coordinate in complete Good Manufacturing Practice (cGMP) training sessions by organization.
  • Distribution and control of documents such as specification, process Operating Instruction (POI), Protocols and other QA documents which is an essential part of GMP guidelines.
  • Prepare departmental Standard Operating Procedure (SOPs) and documentation of all related records in the company which are the foundation stone to all GMP certified manufacturing companies.
  • Documentation for market complaints and product recall.
  • Final review of batch documents and their archival to complete all necessary manufacturing documentation requirements and ease the process of data traceability.
  • Carrying out internal Quality Audits and all related coordination and documentation which is an essential part of GMP guidelines.
  • Collaborated with cross-functional teams to improve overall product quality.
  • Identified root causes of quality issues using problem-solving techniques; resulted in swift resolution and prevention of recurring problems.
  • Compiled comprehensive reports detailing all inspection findings which helped track progress towards set goals.
  • Systematic reporting of test results fostered transparency and accountability across departments.
  • Maintained records of all QA tests with meticulous attention to detail.

Medical Advisor

Aldawaa Medical Services Co. LTD (DMSCO)
Dammam
04.2013 - 09.2013
  • Collaborated closely with colleagues to discuss complex cases, ensuring best practice was followed at all times.
  • Applied evidence-based approach to care; improved effectiveness of treatment plans.
  • Managed outpatient clinics for efficient service delivery.
  • Promoted preventative measures by leading educational sessions at local schools and community centres.

Education

Master of Business administration - International Business

Saudi Electronic University in coordination with Colorado State University (Global Campus)
Dammam, KSA
08.2019 - 08.2020

Bachelor degree - pharmacy

College of Pharmacy. King Saud University
Riyadh, KSA
07.2008 - 06.2012

Skills

  • Problem-solving
  • Communication skills
  • Public speaking
  • Quality Assurance
  • Familiarity with lean principles
  • Root cause analysis techniques
  • Auditing expertise
  • QMS understanding
  • CAPA expertise
  • FMEA experience
  • Auditor certification
  • ISO-9001 knowledge
  • Risk Assessment
  • 5s principles
  • Technical writing
  • Value stream mapping

Languages

English
Fluent
Arabic
Native

Affiliations

  • Adult coloring
  • Fashion

Accomplishments

Founder of Women in Pharma, KSA initiative.

Certification

Professional Accreditation Certificate from Saudi Commission for Health Specialties as a Pharmacist

Custom

  • Speaker and discussion panel moderator for women in Pharma Saudi Arabia, CPHI, Riyadh, 2024
  • Speaker for women in Pharma Saudi Arabia, Pharmaconex, Cairo, 2024
  • Speaker at Pharmaconex, Cairo, 2023
  • MENA Pharmaceutical Manufacturing Virtual Series I, 2021
  • 5th annual MENA Pharmaceutical Manufacturing Congress, Riyadh, 2019
  • Pharmaceutical Operations and Compliance Requirements Balancing in the Arab Region, Cairo, 2017
  • 2nd annual MENA Pharmaceutical Manufacturing Congress, Jeddah, 2016
  • Problem Solving and Decision Making, Dammam, 2023
  • Certified Manager of Quality Based on ASQ BOK, Instructor led online training, 2022
  • ISO 9001:2015 Internal Quality Auditing, Dammam, 2019
  • ISO 9001:2015 Awareness Training Programme, Dammam, 2019
  • Training Program for Technical Manager (Based on SFDA Requirements), Jeddah, 2019
  • Data Integrity, 2019
  • Good Hygienic Practice, 2019
  • Good Documentation Practice, 2019
  • Process Validation, 2019
  • CGMP for Logistics, 2019
  • Vendor Audit and Approval, 2019
  • Introduction to GLP, 2019
  • Cleaning Validation, 2019
  • Pharmacovigilance Basics, 2019
  • Compliance and Audit Preparation, 2019
  • Introduction to Change Control, 2019
  • Recalls and Compliance System, 2019
  • Risk Assessment, 2019
  • Handling of Deviations and Effective CAPA Strategy, 2019
  • Risk Based Qualification and Validation, 2019
  • CGMP Guidelines/Trends for HVAC Qualification and Validation for Pharmaceutical /life- science Sterile and non-Sterile Facility, 2019
  • Streamlined Approach for Design Qualification and Validation of water Purification, Storage and Distribution, 2019
  • Production and Packaging Troubleshooting, 2019
  • Quality culture and enabling life cycle quality improvement workshop, Cairo, 2017
  • Data integrity workshop, Cairo, 2017
  • Veterinary Products System for GCC countries, Riyadh, 2017
  • How to pass an inspection in your pharmaceutical plant workshop, Jeddah, 2016
  • Self, Stress & Time Management, TPM co, 2016
  • Communication and presentation skills (Time Management training), TPM co, 2015

References

References available upon request.

Timeline

Qualified Person

Baxter Company Limited
01.2024 - 05.2025

QA In-Process Supervisor

Baxter Company Limited
01.2020 - 01.2024

Master of Business administration - International Business

Saudi Electronic University in coordination with Colorado State University (Global Campus)
08.2019 - 08.2020

Production Release Team Leader

Dammam Pharma
01.2018 - 01.2020

Plant Technical Manager

Montajat Veterinary Pharmaceuticals Co. LTD.
01.2016 - 01.2017

Medical Advisor

Aldawaa Medical Services Co. LTD (DMSCO)
04.2013 - 09.2013

Quality officer

Tabuk Pharmaceutical Manufacturing Co (TPMC)
01.2013 - 01.2016

Bachelor degree - pharmacy

College of Pharmacy. King Saud University
07.2008 - 06.2012

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Mariam Mohammed Alyousef