Job Description
Sr. No.
Responsibilities
1.0
Issuance and Retrieval of Log Book and Loose Annex
1.1
Issuance and Retrieval of Log book as per request given by concern department.
1.2
Issuance and Retrieval of Loose Annex as per request given by concern Department.
2.0
Batch No allocation
2.1
Batch No assign (allocate) as per production planning given by Production department check required detail (i.e. Product name, brand name, SFG code, FG code Mfg date and Exp date etc) in “BMR/BPR Issuance Requisition” and assign (allocate) the batch no.
2.2
Verification of BMR/BPR Issuance Requisition after allocation of batch Number.
3.0
Issuance and Retrieval of BMR and BPR
3.1
Arrange the photocopy of BMR/BPR from master copy and write down Batch number along with department wise Batch record checklists with Accountability check list for Batch Manufacturing and Batch Packing records same shall be recorded in BMR/BPR issuance register.
3.2
In case of process validation/Optimization/Stability Batches stamp as per intimation provide by concern and same shall recorded in BMR/BPR issuance register.
3.3
Retrieval of BMR and BPR from IPQA after review and batch released.
4.0
Document Master and controlling activity
4.1
All document Master and controlled at Thol location same shall be Master and controlled and distributed as per SOP.
4.2
Allocation of New SOP Number as per SOP
4.3
Intimation of SOP Periodic revision SOP to concern department.
4.4
Update SOP index and take print of updated SOP index Master and distribution to concern department.
4.5
Check SOP as per standard sop, check all required document before effective and prepare Master copy.
4.6
CQA document controlling and distribution as per SOP.
4.7
Disposition form for obsolete artwork controlling and distribution as per SOP.
5.0
Document Review Sheet
5.1
Initiation of Document Review Sheet based on reviewed document and maintain Document Review Sheet Log.
6.0
Preparation, control and distribution of price list
6.1
Allocation of effective Batch Number in form P-1 and entry in Price list and same shall be Master, controlled and distribution to concern department.
7.0
Allocation of Product Code
7.1
As per concern request New Product Code shall be allocated and same shall be updated in Product list.
8.0
MCM/MCP/BMR/BPR
8.1
Update Master list of MCM/MCP/BMR/BPR and issuance and distribution.
9.0
Retention and Disposal of Documents and Records
9.1
Documents kept in document room as per Retention Period and update document list.
9.2
Fill Documents Disposition Form proceed further for document destruction.