Quality on the Floor (QotF)
at Thermo Fisher Scientific
9744 Hoogkerk, Groningen, Netherlands -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 12 Aug, 2024 | Not Specified | 13 May, 2024 | 5 year(s) or above | 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:
- Quality on the floor: direct engagement, real time, of Quality professionals with manufacturing shop floor operations including cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices. Significant shift work may be required.
- Practical application of various risk assessment tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and the ability to directly develop, participate and advise others on the appropriate and efficient application of these processes.
- Advise, facilitate, and support all phases of manufacturing batch documentation development including, but not limited to the initiation, authoring, approval and mastering.
- Quality review and approval of cGMP documentation.
- Alignment of Standard Operating Procedures, documentation practices, laboratory testing, and efficient documentation flows in the Quality release of raw materials, buffers/media and area/equipment.
- Use, scope, development and orchestration of incident investigations toward the goals of both adequately understanding root cause (including causality vs correlation) and avoiding repeated incidence (corrective action, preventative action and effectiveness verification). Handling of deviations.
- Application of cGMP change control.
- Work with complex and comprehensive electronic databases (e.g. Trackwise) to document events related to product quality.
- Support regulatory inspections from readiness exercises through direct agency engagements.
- Operate in a variety of modes as it pertains to risk adjusted Quality oversight models driven by the mode of manufacturing being employed.
- Effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.).
- Execution of internal audits
REQUIREMENT SUMMARY
Min:5.0Max:10.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
9744 Hoogkerk, Netherlands
