30 Jul
|
B&S Group
|
Gujarat
Position : F&D; TT (Sr. Research Associate / Executive Tech Transfer)
Qualification : M.Pharm
Experience : 4-6 Years
Location: Vadodara, Gujarat
Job Timing: (5 Days Working) Monday to Friday and may have to come on Saturday if required.
Working Timings: 11:00am to 08:00pm
Key Responsibilities:
1. Monitor and track the scale-up and technology transfer activities planning, initiation, execution of Pilot BE/ Scale-up/ Optimisation /Exhibit and Validation batches for new and existing projects at WHO GMP facility (Dosage Form: Solid Orals & Liquid Orals)
2. To evaluate gap analysis, risk assessment before start of technology transfer activities for site readiness.
3. Preparation and review of batch size formula, gap analysis with Process Improvement to improve the productivity and Equipment Equivalency Evaluation across all locations.
4. Documentation - preparation and review of documents like MFR, MPR, PVP, PVR, BMR, BPR, Scale up Protocol and Reports, Sampling protocol, Cleaning validation, Stability protocol, Hold time study protocol, Raw material and Product specifications etc. as per regulatory requirements.
5. Give technical and functional input to team for scale-up and technology transfer of solid and liquid dosage forms.
6.
Trouble shooting and optimization of process parameters to minimize risk during tech transfer for new and existing formulations.
7. Suggest and implement cost-saving ideas.
8. Investigate and report all incidents (OOS, OOT etc.).
9. Monitor and track the scale-up and technology transfer activities – planning, initiation, execution of Pilot BE/ Scale-up/ Optimisation /Exhibit and Validation batches for new and existing projects at WHO GMP facility (Dosage Form: Solid Orals & Liquid Orals)
10. To evaluate gap analysis, risk assessment before start of technology transfer activities for site readiness.
11. Preparation and review of batch size formula, gap analysis with Process Improvement to improve the productivity and Equipment Equivalency Evaluation across all locations.
12. Documentation - preparation and review of documents like MFR, MPR, PVP, PVR, BMR, BPR, Scale up Protocol and Reports, Sampling protocol, Cleaning validation, Stability protocol, Hold time study protocol, Raw material and Product specifications etc. as per regulatory requirements.
13. Give technical and functional input to team for scale-up and technology transfer of solid and liquid dosage forms.
14. Trouble shooting and optimization of process parameters to minimize risk during tech transfer for recent and existing formulations.
📌 F&D TT - Executive Tech Transfer (Gujarat)
🏢 B&S Group
📍 Gujarat