Scientist, Facility Compliance
at AGC Biologics
København, Region Hovedstaden, Denmark -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 29 Jun, 2024 | Not Specified | 30 Mar, 2024 | 3 year(s) or above | Role Model,Manufacturing,Pharmaceutical Industry,Environmental Monitoring | 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:
WITH AGC BIOLOGICS INCREASING ACTIVITIES, WE ARE LOOKING FOR A NEW SCIENTIST TO SUPPORT FACILITY COMPLIANCE IN THE PHARMACEUTICAL INDUSTRY.
AGC Biologics is a Contract Manufacturing Organization (CDMO) with facilities in Denmark, Germany, Japan and USA and with customers from all over the world. We have more than 50 nationalities employed and the daily language is English.
EXPERIENCE AND COMPETENCIES
The ideal candidate holds an Academic degree within science and has a strong background within facility compliance and environmental monitoring. The ideal candidate has previously been working with applied microbiology or manufacturing under cGMP within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:
- 3+ years of experience from the pharmaceutical industry working in an cGMP environment
- Strong communicator
- A natural role model and coach for improving aseptic behavior
- Structured and analytically oriented
- Experience with applied Lean
- A genuine interest in being close to the manufacturing floor and understanding the need for process confirmation
As a person you are driven by continuously improving processes and procedures. You are curious, have a good overview, is eager to learn and value being a team player. You thrive in a high pace environment where no two days are the same.
For further information, please contact Yasin Senel, Team Leader, Facility Compliance, phone +45 22943093.
Responsibilities:
- Owners of and responsible for continuously improving the procedures for gowning, aseptic behavior and Flow and Logistic.
- Process confirmations of above procedures
- Evaluation of current and new cleaning procedures
- Support to the manufacturing teams with tasks related to facility compliance handling deviations
- Training of manufacturing associates
- Handling CAPA’s related to deviations
- Handling changes related to facility compliance and EM processes
- Participate in regulatory inspections and audits
- Participate in board meetings, KPI delivery and follow-up
- Optimization and standardization of work processes related to facility complianc
REQUIREMENT SUMMARY
Min:3.0Max:8.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
Graduate
Facility compliance and environmental monitoring
Proficient
1
København, Denmark
