Title: Executive

Date: Mar 21, 2023

Location: Baska 2 Plant

Company: Sun Pharma Medicare 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 machineries.
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 Trouble shooting batches for data comparison and route cause Investigation at CMO.
To ensure that the Packing operations or activities are carried out on timely.
To ensure that the Stability charging of product are 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 authorized person prior going to Exhibit batches & their 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 smooth running of Scale up, Exhibit, Process validation batches.
To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, MBMR.
Accurate and timely reporting of various production activities showing performance and short coming against agreed /planned parameter to report.

Any other responsibility assigned by department head after ensuring the relevant training status.

Execution of technology transfer to CMO/Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries.
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 Trouble shooting batches for data comparison and route cause Investigation at CMO.
To ensure that the Packing operations or activities are carried out on timely.
To ensure that the Stability charging of product are 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 authorized person prior going to Exhibit batches & their 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 smooth running of Scale up, Exhibit, Process validation batches.
To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, MBMR.
Accurate and timely reporting of various production activities showing performance and short coming against agreed /planned parameter to report.
Any other responsibility assigned by department head after ensuring the relevant training status.