Job Description

• 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.