Deviations and CAPAs Process Owner

Job title: Deviations and CAPAs Process Owner

Location: Cairo Site

Hiring Manager: Mostafa El Naggar - Quality Systems and Compliance Manager

About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Job Purpose:

QA systems department plays a vital role in establishment and maintenance of quality system in Sanofi Cairo site to ensure delivery of high-quality products that comply with global quality standards and regulatory requirements.

Job Responsibilities:

Responsible for CAPAs follow up:

·         To follow up the CAPAs implementation on monthly basis.

·         Follow up performance of CAPAs ECs on monthly basis.

Responsible for Deviations follow up:

·         To follow up the Deviation closure on time.

·         Trending non-significant deviations quarterly.

HSE Responsibilities:

·         Ensure HSE approval on any SOP that requires certain HSE precautions.

·         Ensures HSE approval on any change.

·         Follow the laboratory safety procedures.

·         Commitment to the appropriate PPE use.

·         Follow the approved HSE policy and requirements.

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

·         Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

Others:

·         Perform other duties as assigned.

·         Respect of company’s values, code of ethics and social charter.

·         Respect of personal data protection charter.

·         Responsible for applying the HSE-related requirements for the company in all related working procedures.

Section 3: Requirements/Qualifications

Experience

NLT 5 years in Quality management systems.

Past experience in CAPAs and Deviations Management is preferred

Education

Bachelor of Pharmaceutical Science

Soft skills

·         Good communication & Presentation skills.

·         Planning & organizing skills.

·         Problem solving skills.

·         Report writing skills.

·         Ability to co-ordinate several inter-departmental activities.

·         Good command of MS Word, Excel & Power Point.

Technical skills

·         Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).

·         Good command of MS Word. Excel & Power Point.

Languages

English, Arabic

Play To win Behaviors:

• 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

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!