Job Description
Job Responsibility and key Decisions
Planning, executing, monitoring, and controlling the Solubilization, Pegylation, UFDF DS operations as specified in the BMRs SOPs
Operation of equipment like surge vessel, blender, magnetic stirrer, mixer, CIP skid, neutralization tank, fume hood scrubber, TFF, mixing glass vessel, biosafety cabinet, Dynamic Pass box weighing Balances Scales Not limited to.
Operation verification If applicable of Analytical instruments like pH conductivity meter, spectrophotometer filter integrity testing machine Not limited to.
Involving in buffer solution filtration activities
Preparation and filtration of excipients used in the DS process.
Transfer of final DS to other facilities as specified in the BMR SOPs.
Storage of cassettes replacement of storage solutions.
Initiation of notifications in SAP for instrumentsequipments breakdown followup.
Operation of devices like Calculators Barcode Scanning System Not limited to.
Verification, receiving, transfer process wise stage wise segregation of BOM materials.
Completion of trainings before the execution of activities.
Adherence to SOP and good manufacturing practices.
Updating of process material consumption in SAP return of unused materials through SFR if any.
Ensuring the equipment instruments are within the Preventive maintenance Calibration due dates and witnessing the Preventive maintenance and calibration activities.
Routing movement of material on shop floor appropriately.
Sequencing the procedures and processes which are taking place on shop floor.
Identifying the procedural gaps and addressing the same.
Submission of samples to Quality units.
Documenting the operations in appropriate sections of the documents by following GDP.
Identifying and reporting the nonconformities Events and coordinating in investigating the same for the identification of root cause.
Responsible to draft first cut information for deviations, proposal for change control and implementation of CAPAs to ensure high quality GMP standard.
Complying with QA EHS procedures.
Identifying and reporting the EHS related nonconformities Incidents and coordinating in investigating the same for the identification of root cause.
Maintaining appropriate clean room behaviours, health hygiene practices and regularly following personnel entryexit procedures in shop floor.
Escorting the visitors as per the SOP.