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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 controlling and distribution as per SOP.

4.2

Allocation of New SOP Number as per SOP

4.3

Update SOP index and take print of updated SOP index Master and distribution to concern department.

4.4

Check SOP as per standard SOP,



check all required document before effective and prepare Master copy.

4.5

Concern activity related SOP preparation and review.

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

Authorization of correction.

5.1

Issuance and log of Authorization of correction form after approval made correction in Master Copy and controlled copy

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 ID.

7.1

As per concern request Recent Product ID shall be allocated and same shall be updated in Product ID list.

8.0

Review and Master of MCM/MCP/BMR/BPR.

8.1

Review of MCM and MCP as per SOP.

8.2

Review of BMR and BPR as per SOP.

8.3

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.

10.0

Initiation and Impact assessment of Change control.

10.1

As and when Initiation of Change control for document revision.

11.0

Packing Material specification, STP and work sheet.

11.1

Received packing material specification from QC put effective date and Master it and controlled and Distribution.

11.2

Received STP from QC put effective date and Master it and controlled and Distribution.

11.3

Received Packing Material Work sheet Master it and share with QC for further process.

12.0

Deviations activity

12.1

Initiation and assessment of deviation.

13.0

CAPA activity.

13.1

Initiation and assessment of Corrective Action & Preventive Action work on action item as per CAPA.

14.0

Training Related work

14.1

As Authorized trainer conduct training of Refresher training and training related to SOP.

15.0

Technology Transfer

15.1

Handling, review and communicate TT Document as TRU or TTU QA as per product transfer requisition.

16.0

Review of Annual Product Review

16.1

Review of Annual Product Review Report.

16.2

Review Annual Product Review Planner & Summary Report.

16.3

File Extension of APR Review with Justification.

16.4

Handling of Status Marketing Authorization Variation

17.0

Qualification and Approval of contract services

17.1

All document handling, communication, review and proceed as per standard SOP.

18.0

Additional responsibilities assigned by Head of the department.

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📌 Senior Officer QA Thol (Gujarat)
🏢 Troikaa Group
📍 Gujarat