Qualification & Data integrity Officer

Sanofi

Cairo, , EgyptPosted 1 day agoDiscoveredMatch locked

Fixed Term (Fixed Term)3+ years exp

About the job

As Quality Assurance Specialist within our Quality team, you'll make sure our daily operations meet Good Practice (GxP) regulations and Sanofi's internal standards. You'll lead the site's Data Integrity program and oversee the qualification and validation of our equipment and systems, so they stay compliant and fit for their intended use. Your work protects product quality and, ultimately, the patients who rely on our medicines. Ready to get started?

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities

Lead the site's Data Integrity program:

manage the Data Integrity master plan and keep the program running across the site. •

Build data integrity awareness

train all staff on data integrity requirements and follow up on the training of operators and technicians in all areas. •

Drive ALCOA+ practices

work with the data integrity governance team to implement ALCOA+ principles (data that is attributable, legible, contemporaneous, original, accurate, and more) in all areas. •

Plan and review validation activities

confirm the planning and review of activities such as Computer System Validation (CSV), so that systems are fit for their intended use and meet quality standards. •

Review and approve qualification documents

review and approve qualification protocols and internal documentation for equipment and systems. •

Monitor and improve validated systems

monitor validated systems on an ongoing basis and put improvements in place to maintain compliance and efficiency. •

Champion health, safety and environment (HSE)

make sure SOPs and changes that need HSE precautions receive HSE approval, follow laboratory safety procedures and PPE requirements, segregate hazardous substances and waste correctly, and report any accidents or incidents to the HSE department.

About you

Education:

Bachelor's degree in Pharmacy or a science discipline. •

Experience

3-5 years in similar roles. •

Technical skills

Knowledge of GxP, computer system validation, equipment qualification and data integrity principles (ALCOA+). •

Soft skills

Strong communication and training skills, a collaborative mindset, and attention to detail. •

Safety and ethics

Commitment to HSE requirements, Sanofi's values, code of ethics and personal data protection.

Not included in the source posting: what you'll do, benefits.

Skills

artificial-intelligence

Who can apply

The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.

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