Senior QA Specialist - External Manufacturing

Job title: Senior QA Specialist - External Manufacturing

Location: Egypt

Grade: L2

Hiring Manager: QA External Manufacturing Section Head

JOB PURPOSE:

Participate In Management of External Manufacturing quality activities starting from selection of contract manufacturing organizations (CMOs), approval, quality agreement throughout of products transfer, monitoring of CMOs performance to ensure compliance of externally manufactured products to Sanofi and local regulatory requirements.

Participate in external manufacturing activities:

Preparation of Quality agreements with manufacturing subcontractors performing activities on behalf of SANOFI and follow up of its approval.

Following up CAPA implementation of external audits.

Frequent visits to subcontractors to follow up the process and to ensure the compliance to cGMP, SANOFI requirements when applicable and with local regulations.

Participate in externalization projects to CMOs regarding quality activities.

Review of CMOs quality documents including validation documents, deviation reports, change control requests, APRs, products QSMPs within specified timelines.

Conduct gap analysis for CMOs management global guidelines.

Keep QTP module updated with CMOs related information.

Perform final release of toll out products within the specified timelines.

Preparation of external manufacturing quality Monthly report.

Conduct annual quality review for the CMOs.

Participate in the Localization Projects of Clexane and Plavix as Toll manufacturing.

Participate in suppliers & subcontractors audits:

Preparation of annual plan for subcontractors’ audits on yearly basis.

Participate in external audits for suppliers & subcontractors.

Participate of Product Technical Complaints Handling:

Participate in investigating, root cause identification and action plan follow up for all Sanofi Customer Complaints.

Communication and follow up customer complaint investigation related for toll out products at COMs level.

Participate in Quality Risk Management:

Participate in identifying, analyzing, evaluating, controlling, communicating, and reviewing potential or identified risks related to quality and GxP compliance in alignment with global quality documents.

Work as risk assessments facilitator for the assigned risks.

SAP Activities:

Participate in Approval of finished/ semi-finished product recipes on SAP Athena.

Participate in Creation/update of Quality Info Records for materials on SAP Athena.

Participate in Creation of Inspection Plan for materials on SAP Athena.

Perform other duties as assigned.

• 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.
• HSE Responsibilities in case joining HSE Excellence team:
  • Facilitate and guide the employees to implement the HSE&En. Policies.
  • Implement all applicable standards and guides of Sanofi-Aventis in his/her area.
  • Ensure from complying with all legal and Sanofi-Aventis requirements.
  • Lead his/her team to implement the HSE & EnMS PASS.
  • Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.
  • Report any accidents/incidents in his/her area to the HSE department.
  • Lead his/her team for investigate accidents/incidents to define the root cause.
  • Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
  • Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
  • Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
  • Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
  • Define and control the required PPE’s for his/her area.
  • Define the list of CMR and its operational control for Quality labs and production areas.
  • Control the first aid kits in his/her area.
  • Leading his/her team for control the significant hazards /aspects and Energy use.

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.

Education:

• Bachelor of Pharmaceutical Sciences.

Related Experience:

• 5 - 7 years in related GxP area.
• Experience in QA and Validation is a must

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).
• Validation theories, methodologies.

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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team

  
  

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally

  
  

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

  
  

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.

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, 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!

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!