Details of the offer

Mission statements:
1. Ensure audit readiness for all engineering functions and projects undertaken.
2. SME for Engineering QMS.
3. Perform C&Q activities as per the plan for business-critical projects
4. Plan and do improvments in internal capability building to support WHO, European FDA , other regulatory and internal audits.
5. Adoption of global engineering guidelines and drive practices across the engineering function.
6. Manage the QMS with focused on tactical delivery and LRP.
Review the revision and updates of departmental SOPs
Functional approval of qualification documents submitted by vendors
Review the development of DQ, FAT, SAT, Commissioning, IQ and OQ protocols of all systems.
Conduct and compile equipment acceptance tests.

7. Implement quality practices across engineering through identification of training needs and engaging with stakeholders to ensure the compliance of good practices.
Provide training to team as needed and ensure training compliance for all team.
Create and oversee execution of the training calendar.

8. Prepare plan for self-inspection and regulatory audits with SMEs and CFTs.
9. Tracking of departmental (QMS) CAPA, Event and Change control actions for timely closures and timely escalation of anticipated delays to Manager and HOD for needful action to prevent the delay.
Review and submission of change control forms to assess the impact of proposed changes.
Work Plan reviews for engineering activities.

10. Review of equipment, project quality plans as needed.
11. Train employees and review documents to ensure Good Documentation practices in engineering.
12. Audit SPOC and follow up response preparation in coordination with SMEs.
13. Investigate the incidents and submit root cause analysis as needed.
14. Validate data practices to maintain Data Integrity compliance in engineering activities
15. Conduct and review equipment acceptance tests at vendor premises. (Complex equipment need his/ her expertise for tests)
16. Produce QMS reports and MIS weekly, monthly basis.
17. Carry out internal audits for engineering activities.
18. Influence, communicate and manage stakeholders.
19. Internal Stakeholders - TSG Lead, HVAC lead, utilities lead, projects lead, C&Q execution and automation.
20. CFT Stakeholders - Production, QA validation, QC etc.
21. Global stakeholders - Global Engineering Team

Knowledge, Skills & Competencies:
Sound understanding & skills in applying Good Engineering Practices and standards (GEP & GxP)
Hands on experience in handling EU/US FDA audits
Hands on experience in commissioning & Qualification activities.
Hands on experience on Quality management systems (Change control, CAPA, Event)
Good exposure in GDP and Data Integrity concepts.
Knowledge in systems Bio process equipment, utilities and HVAC.
Compute system compliance and practices exposure.
Proven ability to manage audits and vendor coordination.
Good presentation and analytical skills.
Good knowledge in C&Q process and related documentation.Lead competencies:

Act for Change: Embrace change and innovation and initiate new and improved ways of working.
Cooperate Transversely: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.

Language preferable- English, Telugu, Hindi etc.
Degree / Diploma in Mechanical / Chemical / Instrumentation
10- 14 years of experience in the field and 4-6 years in handling similar role / position.
Pharmaceutical / Bulk / biotech / vaccine industry experience is a plus
Experience in handling similar role at US FDA, EU regulatory approved plants.

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.

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