Job Purpose:

Controlling, executing, and improving validation Activities for all process, cleaning and media fill in the site.

Key responsibilities and duties:

1.Validation Master Plan (VMP) Management:

• Validation Master Plan issuance.

• Follow up implementation by various departments.

2.Performing of Manufacturing, Packaging Processes Validation:

• SANOFI guidelines updates & changes review.

• Validation protocols creation.

• Monitoring & checking the various production activities during validation processes & ensuring that they are as mentioned in both Processing batch record & validation protocol.

• Sampling according to validation protocol & providing QC with samples.

• Collecting data from the various departments, analyzing information provided & preparing report to include results & conclusion of validation.

3.Performing of Cleaning Validation:

• Studying the design of the machines & determine the critical points for cleaning.

• Initiating the protocols & follow up distribution to concerned department after approval of concerned managers.

• Following up sampling process.

• Preparing of the report showing the results of cleaning validation.

4.Reviewing & Updating of GMP documents:

• Updating of Master BMRs SOPs, etc....

• Updating our GMP documents according to the last updated Global Quality Documents.

5.HSE:

• Follow the site 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

6.Others:

• Perform other duties as assigned.

• Respect of company’s values, code of conduct and social charter.

• Respect of personal data protection charter.

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

Key “MUST HAVE” competencies, skills & experiences.

Education

• Bachelor of Pharmaceutical Sciences.

Related Experience

• 4 - 6 years` experience in related quality assurance function.

Special Knowledge/Skills

• Good Communication skills with ability to co-ordinate several inter-departmental activities.

• Presentation skills.

• Computer skills (Good command of MS office).

• Sense of urgency, Follow up skills, Time management skills.

• Good Command of English Language,

• Attention to Details, Team Worker, Problem solving skills.

• Report writing skills.

• Validation theories, methodologies & sampling techniques.

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

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.