Job responsibility QA officer IPQA
Job Summary:
To execute, and perform daily activities related to In Process Quality Assurance as per laid down
procedures and systems. He is responsible for all below mentioned activities:
Job Responsibility
1. Ensure line clearance activity for all stages in different areas.
2. Ensure monitoring of environmental conditions in different areas.
3. Ensure the process as per cGMP requirements.
4. Ensure dispensing activities as per written instructions (SOPs).
5. Ensure the monitoring of all processing activities as per Batch Processing record.
6. Ensure in process control during the processing of Tablet, Capsules, Oral liquids & External Application preparations.
7. Ensure correct Status labels at all materials as per stage.
8. Ensure online filling of Batch Processing records during processing.
9. Ensure process validation activities on floor.
10. Ensure yield of batches at every stage as per prescribed limits.
11. Ensure the sampling of semi-finished & finished products as per respective SOP`s.
12. Ensure approval of overprinting details before starting of overprinting activities.
13. Ensure packing of batch as per approved packing instructions.
14. Ensure the sampling of control sample and stability sample as per SOP.
15. Ensure transfer of batches to FG Store after closing of Batch processing record.
16. Online Review of BMR/BPR.
17. To coordinate with other departments as per requirement.
In the absence of candidate suitable person will be deputed to perform the above activities by HOD.
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Responsibility Assigned by : _________________ (Sign) Name :
Dated : _________________
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Responsibility
Accepted by : __________________ (Sign) Name :
Dated : _________________ |
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
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process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
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Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
Cleaning Validation of Equipment
Measurement and Recording of Temperature and Relative Humid
Sampling of Product at Intermediate Stages
Approval of Overprinting on Packing Material
sop for Procedure for Reprocessing
Preparation and Control of Master Batch Production and Control record
Issuance and Retrieval of Control documents
Calibration Policy for equipment
procedure for batch numbering system for products
sop for Handling of Incident during operation
Procedure for Allocation of Numbers for Machine Equipment
Validation and Qualification Facility System and Equipment
In-process Checks During Packing Operation
Operation and Calibration of Leak Test Apparatus
Operation and Calibration of Friability Tester
Access to Authorized Persons in Critical Areas
Operation Cleaning and Calibration of Digital Vernier Caliper
sop for Sampling Procedure for Finished Product Samples
Job Responsibility for Engineering
Job Responsibility for Quality Control
Job responsibility QA officer in process