Posted By
ORBION PHARMACEUTICALS PRIVATE LIMITED
Recruiter at ORBION PHARMACEUTICALS PRIVATE LIMITED
343
JOB VIEWS
40
APPLICATIONS
0
RECRUITER ACTIONS
Posted in
SCM & Operations
Job Code
1356742
Qualification : M.Pharm/PG
Job Description:
- Responsible for executing and monitoring of trial, scale up, exhibit and validation batches manufacturing for solid orals (Tablets, Capsules, Pellets and Liquid orals)
- Prepare summary report for the batches manufactured.
- Co-ordinate with R&D, Production and other CFT for smooth transfer of Technology from exhibit batch to production scale-up.
- To follow the standard operating procedures and safety precautions.
- Trouble shooting activities to be performed (if any) during the manufacturing of exhibit batches, validation / commercial batches.
- To support in activities related to manufacturing feasibility verification.
- Design and develop technology transfer protocols and other protocols (Sampling , Stability and other related protocols ) for different dosage forms.
- To finalize the batch size for scale up, exhibit, commercial batches and provide bill of materials & quantities.
- To evaluate gap analysis for manufacturing at external site and provide risk assessment for the same.
- To evaluate feasibility changes in product life cycle management.
- To prepare, review and approve Hold time protocols and hold time reports
- To provide justification reports for OOS, OOT, Deviation and Temporary changes with respect to Exhibit, Commercial manufacturing.
- To prepare Technology Transfer Dossier.
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Posted By
ORBION PHARMACEUTICALS PRIVATE LIMITED
Recruiter at ORBION PHARMACEUTICALS PRIVATE LIMITED
343
JOB VIEWS
40
APPLICATIONS
0
RECRUITER ACTIONS
Posted in
SCM & Operations
Job Code
1356742