Quality Assurance Officer

How will you CONTRIBUTE and GROW?

Compliance with local regulations, Egyptian Drug Authority, Air Liquide Standards and ISO 9001:2015, 14001:2015, 45001:2018

and FSSC 22000 for sampling, analysis and quality inspections as per the sampling plans, GxP practices and quality steering.

Playing the central supervisory role of the Internal Audits, Quality/ GxP operations ,Pharmacovigilance officer and product release .

1- In Process Controls Process Supervision

• Assure that all quality gates are implemented, maintained and reviewed.
• Assure that all FSMS CCPs and OPRPs are monitored, evaluated and are properly functioning.
• Supervise the QC sampling plan fulfillment and operations fulfillment to Air Liquide Egypt IMS structure.
• Investigate NCs, quality complaints and close the loop accordingly.
• Manage FSMS , GxP and Integrated ISO External Audit.
• Manage Internal Audits .
• knowledge is continuous improvement tools: 6 Sigma - RCA
  
  
  

2- Validation Activities Focal Point in Medical Sites .

• Machinery Validation for ASU/GFS.
• Facility Qualification.
• Product Quality Review Owner (PQR)
• Product Validation Owner.
• Analytical Method Validation of All ALO activities.
  
  
  

3- Ensure verification activities of analytical equipment

• Verification activities of analytical equipment and their relevant procedures.
• Monitoring the Validation of analytical methods and their impact on reading confidence by Implementing the needed criteria guided by
  
  
  

manufacturers references and technical know-hows for the analyzed molecules.

4 - Internal Audit , External audit , Document control and regulatory compliance.

• Focal point for DC management in ALO related to GxP activities.
• Focal point for regulatory communications with GxP entities (EDA, NFSA etc.)
• Local Pharmacovigilance Officer for ALE Medical Gases .
• Focal Point for Document control (Procedure & handling & auditing )
• Lead Internal auidt 2 Years Cycle
• Facilitate External Audits Cycles
  
  
  

5 - Local Pharmacovigilance Officer activities .

The LPO’s responsibilities include, but are not limited to:

• Deployment, update, compliance and training on the Local Pharmacovigilance SOP
• Managing activities described in the pharmacovigilance agreement (PVA).
• Having a Deviation and Audit Management system including pharmacovigilance activities
• Notifying immediately ALSI-Vigilance and the local Competent Authorities (if applicable) of
  
  
  

any relevant local changes (LPO and/or contact details).

• Notifying immediately ALSI-Vigilance of any safety issue arising in the territory
• Answer in a timely basis to any query of ALSI-Vigilance
  
  
  

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Are you a MATCH?

Pharmaceutical Background

Certification and Training: Quality Certificates/ISO 9001:2015 14001:2015,

45001:2018 . GMP and FSSC 22000 Training

Industrial Gases Operations experience ,Quality Assurance ,Instrumentation and Gas Analyzers

Our Differences make our Performance

At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.

We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.