Sanofi India Hiring | Manager | Degree/ Diploma in Mechanical/ Chemical/ Instrumentation |

Spread the love

Position – Manager
Sanofi India Ltd
Exp. – 4 to 7 years

Job description

  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.
  7. Implement quality practices across engineering through identification of training needs and engaging with stakeholders to ensure the compliance of good practices.
  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.
  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

Qualifications:

  • Language is 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 a similar role/position.
  • Pharmaceutical / Bulk/biotech/vaccine industry experience is a plus
  • Experience in handling similar roles at the US FDA, EU regulatory approved plants.


Spread the love