Job Responsibility for Quality Control
Job Summary
To plan, organize, coordinate and control daily activities related to quality control as per laid down procedure
and systems. He is responsible for all below mentioned activities:
Job Responsibility
1. To ensure that all necessary testing is carried and the associated records evaluated.
2. To approve or reject raw materials, packing materials, intermediates, bulk and finished products.
3. To reviewed specifications, sampling instructions, test methods and other Quality Control procedures.
4. To ensure the qualification and maintenance of his/her department, premises and equipment.
5. To ensure that the appropriate validations are done.
6. To ensure that the required initial and continuing training to his department personnel is carried out and
adapted according to need.
7. The authorization of written procedures and other documents, including amendments.
8. To ensure maintenance of plant hygiene.
9. The approval and monitoring of suppliers of materials.
10. To ensure the retention of records.
11. The monitoring of compliance with the requirements of Good Manufacturing Practice.
12. The inspection, investigation and taking of samples, in order to monitor factors which may affect product quality.
13. Participation in management reviews of process performance, product quality and of the Pharmaceutical
Quality System and advocating continual improvement.
14. To ensure the required documentation like COA is completed in time of approving or rejecting
and RM/PM, sampling instructions.
15. To implement discipline, team work and good working atmosphere in the department.
16. To participate and contribution in achieving company objective as directed by the management.
17. To establish system, SOPs and documentation as per cGMP requirements.
18. To develop and check the artwork for new or existing products.
19. To release the finished product batch for sale / distribution.
20. To ensure the calibration work of laboratory instruments.
21. To develop methods for product testing.
22. To conduct audit and necessary documentation.
23. Responsible for overall responsibility of department.
- 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
