JOB PURPOSE:

Maintain & manage QA shopfloor to ensure building of quality into the product in order to guarantee the conformance of the final product with its specifications and compliance to GMP regulations, Sanofi industrial quality and compliance directives.

KEY RESPONSIBILITIES AND DUTIES:

Finished Products batch disposition.

- Manage batch release activity for all Sanofi Manufacturing and supply products to achieve the market demand.

- Accelerate batch release activity to achieve the Quality QA release cycle time and PCT.

- Diversifying team experience to maintain effective business continuity.

- Regular close follow up with other stakeholders’ logistics, PD & quality control teams to organize and improve activity in term of rupture closure, quality stock & PCT

Deviation System Management:

- Led the project for the implementation of the new minor workflow with associated tools DGBI & Power BI in Cairo Site for continuous monitoring and improving deviation closure process & Cycle time.

- Start Implementation of DGBI.

- Leading the project for implementation of deviation management system using Qualipso wave II.

-managing the investigation process for all production/product impact related deviations including OOS & OOT in compliance with the global requirement and guidelines.

- Diversifying and improving team members in the deviation management process
Product Quality Review:

Managing product Quality review system and execution correctly.

Process Observation & Gemba Walks.:

Ensure that quality tours & process observation are taking place within each production area.

Quality compliance:

- Perform Mix up awareness campaign for operators and staff.

- Manage the quality culture program for the site..

Contamination Control Strategy::

- Training the Quality staff for CCS.

Batch Recall.
Training Management:

- Support in conducting the assigned training as per annual training plan

Data Integrity:

- Ensure the Compliance with ALCOA+ principles and correct implementation of data integrity in production area.

HSE Responsibilities:

1. Assure the full implementation of all action plans related to HSE, within plant logistics scope

2. Commitment to the appropriate PPE use.

3. Follow the approved HSE policy and requirements.

4. Following the statutory legislation concerning Health, Safety and environmental law.

Education:

Bachelor of Pharmaceutical Sciences or Bachelor of Sciences

Related Experience:

Over 7 years’ experience in related field

Special Knowledge/Skills:

Computer Skills: SAP Athena.
Language Skills: Arabic & English
Appropriate HSE Knowledge
Multitasking
Hardworking
Good communication skills
Leadership and people management skills

Competencies:

Stretch to go beyond the level we have operated at up until now
Take actions instead of waiting to be told what to do
Act in the interest of our patients and customers
Put the interests of the organization ahead of my own or those of our team
Act for Change, Strive for results, Cooperate Transversally, Commit to Customer
Think Strategically, Lead Teams, Develop People, Make Decisions

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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.css-o171kl{-webkit-text-decoration:none;text-decoration:none;color:inherit;}Quality Assurance Shop Floor Section Head

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Quality Assurance Shop Floor Section Head