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.
Others:
Education:
Related Experience:
Special Knowledge/Skills:
Competencies:
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!
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.