Ahmad Baqazi,  Quality Assurance Manager

Ahmad Baqazi

Quality Assurance Manager

Sandoz

Lieu
Arabie Saoudite - Jeddah
Éducation
Master, Biotechnology
Expérience
10 years, 4 Mois

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Expériences professionnelles

Total des années d'expérience :10 years, 4 Mois

Quality Assurance Manager à Sandoz
  • Arabie Saoudite - Jeddah
  • Je travaille ici depuis juillet 2023
Quality Assurance Manager à Acino
  • Arabie Saoudite - Jeddah
  • mai 2022 à juillet 2023

Quality Assurance Manager

Quality Assurance specialist à Abbvie
  • Arabie Saoudite - Jeddah
  • février 2019 à mai 2022

- Ensures quality of drugs, biologics, devices following regulations.
- Designs quality systems to be efficient and compliant.
- Analyzes data to identify and address quality risks.
- Conducts audits to find and fix compliance gaps.
- Supports inspections and helps resolve any issues found.
- Trains and manages a quality assurance team.
- Investigates quality problems and takes corrective actions.
- Works with manufacturers to investigate product issues.
- Communicates with regulatory bodies about complaints.
- Manages the complaint system and prepares customer responses.
- Monitors and qualifies performance of key suppliers.
- Conducts internal quality inspections.
- Manages change control to avoid negative impacts.
- Provides guidance on Good Storage and Distribution Practices.

QA Management & NPD Officer à Savola Group
  • Arabie Saoudite - Jeddah
  • mai 2017 à février 2019

1.Insure quality standards set forth in SOP and cGMP.

2.Write SOPs and work instructions

3. Work with managers and teams to assess and ensure compliance with cGMP and company compliance plan against internal (policy/procedure) and external (contract/program) requirements; report regularly on results

4. Develop and maintain food safety plans (HACCP), as well as performing the function of active team leader .

5.Conduct food safety and quality training in various formats to meet the needs of the employees within the parameters of their positions to consistently produce employees who are well trained in the skills and requirements of their position.

6.Maintain all records pertaining to personnel training for food safety and quality .

7.Provide guidance and leadership up to and including operations management in situations where deviations have occurred or a potential risk has been identified related to food safety and/or quality .

Quality Assurance &Quality Control Officer à Arabio
  • Arabie Saoudite - La Mecque
  • janvier 2016 à mai 2017

Issuance, Archival, Retrieval of documents and Labels including but not limited to:
* Masters and Executed Batch Records
* SOPs Masters and obsolete SOPs
* Masters Specifications and Test Procedures
* Completed Deviations, Out of Specification Reports & Ems
* Completed Change Controls
* Completed Audit Reports and Responses.
* Completed CAPAs report.
* Issue Batch records to floor for execution
* Prepare database for archival and retrieval of documents.
* Initiate SOP/Standardized QCP templates and Training.
* Logbook issuance and maintenance
* Audit Document Support
* Labeling Supplies for projects, Stationary supplies for department.
* ADDITIONAL RESPONSIBILITIES: Work closely with Operations department to assist them in implementing and maintaining effective, risk based GMP processes, procedures, documentation and Artwork issuance.

Microbiologist à Arabio
  • Arabie Saoudite - La Mecque
  • février 2014 à décembre 2015

Working as Microbiology specialist at Quality control department and through working in microbiology laboratory, I got Optimum knowledge about the following:

*Preparation of Media, Rinsing fluids & bactericidal reagents
*Media pouring techniques
*Preparation, incubation & Monitoring environmental plates for sterile areas
*Gram satin and further identifications (BBL Crystal)
*Microbial limit test for finished products ((Non-Sterile)) and raw materials
*Standardization for control inoculum
*Growth promotion test for medias
*LAL test for WFI & Bulk
*Label claim assay test
*Validation of expiry date for solid and liquid media
*Validation of efficacy and expiry date for disinfectant and sporicidal
*Biological indicators Verification of count
*Biological indicators challenge test
*Validation of efficacy of pass through box
*Sterility area qualification For entering and sampling process
*Routine analysis for water sampling points PW & WFI
*Environmental monitoring during production processes for sterile area and non-sterile areas
*Sampling techniques .
*Got optimum knowledge about the following Machines and Equipment: Autoclave (Fedgari), Oven (Memmert), BBl crystal, LAF, Air sampler device, BD phonex, vortex, Hot plate, PH meter, Balance .

Éducation

Master, Biotechnology
  • à University of Queensland
  • mars 2012

The use of biological processes, organisms, or systems to improve products.

Baccalauréat, Biology
  • à Umm Al-Qura University
  • décembre 2007

BS of biology and diploma in education. Subjects included: • Microbiology. • Zoology. • Cell biology. • Laboratory instrumentation techniques. • Organic chemistry. • Biochemistry • Biometrics. • Vertebrata. • Entomology. • Biological analysis. • Economic Botany.

Specialties & Skills

Microbiology
Pharmaceutical Research
Laboratory Analysis
Biochemistry
managing
Leadership
Communication
computer

Langues

Arabe
Expert
Anglais
Expert

Formation et Diplômes

VITEK 2 system for rapid microbial identification (Certificat)
Date de la formation:
December 2014
Completion for Quality Consultant for QMS - ISO 9001:2015. (Certificat)
Date de la formation:
October 2016
Registration of Process and Quality Management for Efficiency and Effectiveness Course (Formation)
Institut de formation:
Institute of Consulting Research and Studies
Date de la formation:
April 2016
Durée:
16 heures

Loisirs

  • Travelling, Sport
    I enjoy travelling a great deal. I used my holidays at university to travel to Australia,Malaysia, Indonesia and Singapore. I found this a great experience, and it has helped me broaden my cultural knowledge and awareness. Sports: I regularly attend a gym for workout .