Quality Assurance Manager (all genders)
at Bayer
Darmstadt, Hessen, Germany -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 20 Jan, 2025 | Not Specified | 21 Oct, 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:
- Support in the implementation and continuous improvement of the quality management system taking into account the group guidelines (Compliance Management System) as well as the relevant national and international regulations for good manufacturing practice (GMP) at the site
- QA expert and IT contact for compliance and implementation of data integrity requirements at PSDC Darmstadt
- QA oversight in the area of computer system validations (CSV) in close cooperation with the specialist departments
- Conducting GAP analysis and defining and implementing appropriate measures to improve and optimize data integrity requirements at PSDC Darmstadt
- Recording and evaluating deviations as well as corrective and preventive measures and change procedures and their follow-up in the area of responsibility
- Preparation and approval of risk assessments and risk analyses in the area of responsibility
- Regular review and updating of the work instructions (SOP) relevant to the area of responsibility
- Support in change management (coordination)
- Willingness to cooperate and, if necessary, lead cross-site projects in the quality area
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Software Testing, Clinical Pharmacy
Graduate
Proficient
1
Darmstadt, Germany
