Role & responsibilities - Handling of Stability Sample- Preparation of Protocol and report of stability- To ensure that the stability study shall be carried out as per stability calendar - Handling Retain sample - Temperature monitoring of stability and control sample room - Handling QMS Activity - Audit Handling - Document Review - QC, ADL and F&D. Preferred candidate profile:- Handling of QA Stability and Retain Sample Perks and benefits

Role & responsibilities: Documentation and Qualification of Project To prepare the User Requirements Specification of Warehouse - Injectable Project related Equipment. To Qualify the equipment as per the order of qualification. To sort out the discrepancy related to equipment qualification and documentation and resolve same in co-ordination with vendor and cross functional departments. To review the qualification related documents of new equipment. To prepare, review, update and follow the SOPs. To assist / support in installation of Equipment / Systems in plant. To conduct, execute the FAT of new equipment. To involve / support / direct IQ, OQ and PQ activity and documentation of the same for the equipment / Instruments / machine. To review Qualifications protocols of Equipment. To review all the documents related to Warehouse department. Periodic validation & Qualification To execute / support and review the IQ, OQ and PQ activity of new equipment and periodic qualification activity of the equipment related to Warehouse - Injectable departments. Audit, Audit compliance, Training and other To review and maintain the cGMP compliance of facility. To conduct SOP training / guideline training. To prepare Purchase Requisition & to maintain minimum stock of inventory related to Plant consumable. To support project team for ongoing Projects. To provide updates and guidance about regulatory requirements in the form of training. To conduct internal, cross functional audits along as per audit schedule. To allocate the work to manpower as per requirement and maintain discipline in the area. To find out the requirements of miscellaneous materials and consumables related to area. Warehouse Management To receive the Raw Materials, Packing Materials and Consumables Materials. To reconcile the Receiving materials against Purchase order. To prepare GRN against material receipt. To put and verify the tags of status labels of materials and equipments. To store the materials as per storage condition. To Dispense the Raw Materials against process order and requirement from production. To issue the Packing Materials against process order and requirement from production. To prepare invoice for FG dispatch. Coordinate with vendor or Procurement team for Reject Material – return to vendor. Coordinate with vendor or Procurement team for timely supply of materials. Coordinate with QC for Sampling and Releasing of materials. Quality Management system To initiate, review, monitoring of the Quality Management System (QMS) documents such as Change control, Deviation, risk assessment and investigation reports, CAPA, etc. To coordinate with cross function departments for approval of QMS. Energy / Costs saving & Others To identify the energy saving ideas without compromising in quality. To optimize the operation cost by optimum utilization of resources. To find out the scope of cost saving for the operational activities and implementation of same. Any additional activity given by superior. Preferred candidate profile Perks and benefits