sop for Job Description
1.0 Objective
To lay down a procedure for preparation of Job Description for all employees
in the organization.
2.0 Scope
This SOP is applicable for personnel working in formulation plant of ABC Pvt. Ltd.
3.0 Responsibility
3.1 Supervisor / Officer/ Executive, Human Resource Development and Concerned Department
shall be responsible for implementation of this SOP.
3.2 Head QA / designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
HOD : Head of Department
No. : Number
Job Description : A broad statement of the job title, job summary, job responsibilities.
Key Positions : Those positions which are at the HOD level and important technical personnel.
5.0 Procedure
5.1 For any new joinee in the Company, a job description (refer Annexure–1) shall be prepared
by the respective HOD/ designee.
5.2 On joining the services of the Company, the new joinee shall be given the Job Description
duly completed and signed by Head-QA/ his/her designee.
5.3 The new joinee shall, after reading the said job description, put his/her signature at the
specified place with date and return copy to the HOD.
5.4 In the absence of the job holder substitute designee shall responsible for overall
responsibility assigned to job holder.
5.5 Substitute designee read the job description of job holder and then put his/her signature
at the specified place with date for confirmation.
5.6 All job descriptions distribute to individuals as per key positions and responsibility
never overlapping to each one.
5.7 The job description may be reviewed when the assigned job change or person shift to one
area of working to other area, normally job description review / revised once in a two years
(if required) by respective department HOD/ designee.
5.8 Job Description shall be given a number by QA personnel and shall be logged as per the format attached as Annexure-2.
5.10 All original Job Descriptions shall be filed by Documentation Cell-QA.
6.0 Forms and Records
6.1 Job Description Format – Annexure-1
6.2 Job Description Record – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance, Quality Control, Production, Warehouse,
Engineering and Personnel & Administration.
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
- 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
-
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
-
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
Procedure for Issuance of Extra Raw Material Packing Material
Numbering System for Level One Master Document
