Validation and Qualification Section Head

JOB PURPOSE:

Qualification and validation section head managing qualification, calibration, validation & CS

KEY RESPONSIBILITIES AND DUTIES:

Qualification of New Projects:

• Issue / review of validation master plan for new projects.
• Issue / review all the new projects related qualification packages (Protocols & Reports) whether issued internally or supplied from third parties.
  
  

Validation Activities:

• Establishment of the validation master plan, following up & updating of the implementation by various Departments.
• Issue / review the Cleaning & Process Validation protocols & reports to ensure compliance with SANOFI guidelines.
• Issue / review the Media Fill test protocols & reports.
  
  

Qualification & Calibration of the current Routine Activities:

• Issue / review the annual Calibration & Qualification plans for the site.
• Ensuring the compliance & execution of the calibration and calibration activities as in the plan.
• Approve the Calibration certificates of the calibration plan.
• Issue / review the Qualification activities in the plan. (Protocols & Reports)
  
  

Computerized System Compliance:

• Issue / review the Computerized System Inventory for the site equipment.
• Ensure updating of the Inventory on annual basis.
• Issue / review the computerized system qualification packages (protocols & reports) & ensure compliance with Sanofi guidelines.
• Perform review of GAP analysis of the systems in compliance with data integrity requirements.
• Ensure presence of GAP analysis plan for data integrity compliance requirements.
  
  

HSE Responsibilities:

Ensures 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.
  
  

JOB-HOLDER’s ENTRY REQUIREMENTS:

Education:

• Bachelor of Pharmaceutical Sciences or Bachelor of Sciences
  
  

Related Experience:

• 5-7 years of experience in quality assurance functions.
  
  

Special Knowledge/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.
• Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
  
  

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.