Back to jobsEnsure GMP standards of secondary repackaging areas are implemented and maintained and to ensure compliance with the Secondary Repackaging.
Coordination with Quality for the effective management of deviation, product/materials non-conformity, and product complaints related to secondary repackaging (includes investigations and corrective actions).
Ensure the efficient operations of secondary repackaging and orders are handled as planned.
Ensures starting materials/packing materials and equipment for secondary repackaging are available and correct.
Prepare/review the RBR for all the secondary repackaging products and ensure the RBR record is available for each batch of the product to be repacked.
Receiving of product to be repacked and packing material from the Warehouse and performing final reconciliation after repackaging is done.
Perform Line Clearance of the area
Perform a demonstration of the packaging procedure of each redressing instruction to the relevant repackaging workers/staff and confirm one unit of sample prepared by repackaging workers/staff.
Perform in-process control during the repackaing activity as per frequency mentioned in secondary repackaging.
Perform reconciliation of Product and Packing Materials and fill in the RBR
Perform post-line clearance activity and inform to QA of finished product inspection and product release
Ensure all the persons entring the secondary repackaging area to follow the gowning instructions and follow personal hygiene
Ensure all the premises and equipment comply with SOP requirements and ZP standard
Prepare the redressing log sheet and send this to Operations Manager monthly.
Ensuring strict follow the quality policy, 5S, GMP, GSDP, SOP requirements as well as safety guidelines.
Additional tasks assigned by the Operations Manager are willing to accept the new assignments.