Shift Incharge Production

Person needs to have experience of Shift incharge role in any reputed API company.

Role

Qualification

Experience

To follow the entry and exit procedure of the manufacturing blocks including chemical and Pharma areas.

• To clean all equipment’s as per cleaning SOP, Procedure and PCR
• To discuss and get updated for the ongoing and completed operations during the shifts and take the appropriate charge handover.
• Ensure the equipment /area status board updation after operational activities.
• Performing the visual cleanliness verification of the operational equipment before starting the operation
• Operate the equipment’s but not limited to, like reactor, filtration equipments, dryers, powder processing equipment.
• Charging and discharging of materials as per the approved batch manufacturing records.
• Sampling of in process and intermediates and sending the samples to QC for analysis.
• Packing and labelling of intermediates, drug intermediates and drug substances.
• Operation of utility systems as per the requirement
• Ensuring the completion of preventive maintenance and calibration of equipment and its accessories as per the defined schedule.
• Ensuring completion of the general /breakdown maintenance and permit system as per the requirement.
• To ensure that the solid and liquid wastes are disposed off, along with its documentation.
• Ensure completion of performance qualification /verification of the equipment as per the requirement.
• Creation of process order in SAP for the raw materials, packing materials as per the requirement for batch processing.
• Preparation of the material requisition slip for the issuance of raw materials, packing materials as per the requirement.
• To ensure that the completed batch records are submitted back to QA for review and archival.
• To comply the review observations by QA in the batch records.
• To verify the equipment and areas before line/area clearance activities and witness the clearance.
• Generation of the in process, intermediate and other status labels and affixing the same as per defined procedure.
• To perform the activities related to preventive/general/breakdown and calibration in SAP.