Title: Senior Officer
Date:
Oct 22, 2024
Location:
Halol 1 - MSTG - Formulation
Company:
Sun Pharmaceutical Industries Ltd
- Execution of technology transfer to CMO/Site transfer, Scale-up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials, and machinery.
- Documentation work like New production introduction form, Scale-up reports, review of CMO BMR, sampling plan, PV protocol, URS preparation, Dashboard preparation.
- To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality.
- Responsible for Review & comments of MF, FMEA, RA & protocol (Sampling plan, Process validation protocol), and compliance.
- Handling & Support of Troubleshooting batches for data comparison and route cause Investigation at CMO.
- To ensure that the Packing operations or activities are carried out on a timely.
- To ensure that the Stability charging of product is done on timely
- To monitor & prior checkup of equipment planned for usage in Scale-up, Exhibit, Process validation batches i.e. Equipment preparation, vial washing & dehydrogenation, CIP/SIP System, PLCs, instruments, etc.
- To prepare the Scale-up report, get evaluated and signed by an authorized person prior to going to Exhibit batches & submitted to QA.
- Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality.
- Close coordination with all the supporting departments i.e. Production, NPQC, QA, QE (Engineering), and warehouse for the smooth running of Scale-up, Exhibit, and Process validation batches.
- To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.
- Accurate and timely reporting of various production activities showing performance and shortcomings against agreed /planned parameters to report.
Any other responsibility assigned by the department head after ensuring the relevant training status.