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Position – Manager
Sanofi India Ltd
Exp. – 4 to 7 years
- Ensure audit readiness for all engineering functions and projects undertaken.
- SME for Engineering QMS.
- Perform C&Q activities as per the plan for business – critical projects
- Plan and do improvments in internal capability building to support WHO, European FDA , other regulatory and internal audits.
- Adoption of global engineering guidelines and drive practices across the engineering function.
- Manage the QMS with focused on tactical delivery and LRP.
- Implement quality practices across engineering through identification of training needs and engaging with stakeholders to ensure the compliance of good practices.
- Prepare plan for self – inspection and regulatory audits with SMEs and CFTs.
- 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 of equipment, project quality plans as needed.
- Train employees and review documents to ensure Good Documentation practices in engineering.
- Audit SPOC and follow up response preparation in coordination with SMEs.
- Investigate the incidents and submit root cause analysis as needed.
- Validate data practices to maintain Data Integrity compliance in engineering activities
- Conduct and review equipment acceptance tests at vendor premises. (Complex equipment need his/ her expertise for tests)
- Produce QMS reports and MIS weekly, monthly basis.
- Carry out internal audits for engineering activities.
- Influence, communicate and manage stakeholders.
- Internal Stakeholders – TSG Lead, HVAC lead, utilities lead, projects lead, C&Q execution and automation.
- CFT Stakeholders – Production, QA validation, QC etc.
- Global stakeholders – Global Engineering Team
- 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.
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