Quality Compliance Stability Specialist
at Sanofi US
Waterford, County Waterford, Ireland -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 28 Aug, 2024 | Not Specified | 29 May, 2024 | N/A | Good communication skills | No | No |
Required Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
Responsibilities:
- Management of stability programs including generation of protocols and reports, sample management, compilation of results and communication to both internal and external stakeholders
- Trending and statistical analysis of stability and release data for quarterly reports and Periodic Product Reviews (PPRs) Raising and on time closure of Stability, PQR and trending related Quality System records including assigned Change Controls, Deviations, CAPAs, ILIs & QEs
- Ensure effective co-ordination and support for external and internal audits for the department
- Perform critical / constructive review of Stability, PQR and trending related procedures and practices
- Identify and lead projects to make step change improvements to the department’s Quality
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Information Technology/IT
Pharma / Biotech / Healthcare / Medical / R&D
Other
Graduate
Proficient
1
Waterford, County Waterford, Ireland
