01.
He is authorize to sign (as a Doer/Checker/Reviewer/Approver):
Parenteral GMP documents.
Batch record.
Process Validation protocol.
Daily observation compliance.
Departmental SOPs and Study Protocol.
Initiator/Reviewer and Approver in Change control.
Assign to person in CAPA.
Initiator and lead investigator in incident and investigation.
02.
Approval authority:
Extra page issuance form / protocol issuance form.
Perform impact analysis on product quality during breakdown memo approval.
Approval of All QMS document form Production and packing point of view.
03.
Witness key operation:
Equipment cleanliness.
Start-up activities.
Line Clearance.
04.
Verify key activities:
Equipment cleaning and usage log.
Documentation practices.
Labelling practices throughout operation.
05.
Preparation or assist of various protocol(s) or report(s), as required in execution of process validation, cleaning validation/verification and characterization batches.
06.
Execution of training for internal Production department, other cross functional department(s) and contract persons.
07.
Escalate compliance concerns to seniors and Quality department.
08.
Preparation and reviewing of process related log books, SOP(s), BPR and other relevant documents.
Commissioning, installation and qualification of area(s), equipment(s) and machine(s) as per requirement.
09.
Indent of material (SS items, consumable items and other miscellaneous material required for smooth production operation (PR creation).
10.
Involving in planning, execution as per planning and allocation/managing of manpower.
11.
Responsible for all production activities in parenteral department.
12.
Handling of additional activities / tasks allotted by HOD.
13.
All SAP related Work to be execute.