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 instruments/equipment's breakdown & follow-up.
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 non-conformities / 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 non-conformities / 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 entry/exit procedures in shop floor.
Escorting the visitors as per the SOP.
Qualifications
B.Tech/BE/MSc (Biotechnology/Bio Chemistry)
11+ years of experience in Biopharma Manufacturing
