1.0
|
PURPOSE
To insure that in process
parameter are in control and set parameter are being followed consistently..
|
2.0
|
SCOPE
This procedure is applicable to all dosage form at Company
Name.
|
3.0
|
RESPONSIBILITY
IPQA Chemist
|
4.0
|
ACCOUNTABILITY
Head Quality Assurance
|
5.0
|
PROCEDURE
|
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
|
The job responsibility
shall be finalized between the employee and Department Head and shall be
documented.
Department head shall
provide the reference to document, guidelines procedures for better clarity
of activity.
In case of revision or additional responsibility,
Department Head shall discuss the new responsibility / additional
responsibility with the employee.
The revised / additional responsibilities shall be
documented along with the existing Job Responsibility.
For job responsibility of
new employee and new responsibilities of existing employees, Department Head
shall be responsible for training for the job.
Concern Deptt. Head shall
be responsible for describing, reviewing and authoring the job
responsibilities for Department Head(s).as per annexure I.
The date of signing job
responsibility shall be considered as the effective date of the job
responsibility.
Job responsibility of a
person shall be reviewed “Once a Year” or whenever change in responsibility
or for assigning additional responsibility.
Obsolete” job
responsibilities shall be destroyed by shredding.
Records for shredding of
“Obsolete“job responsibilities shall not be maintained.
|
7.0
|
ANNEXURES
|
Annexure No.
|
Title of Annexure
|
Format No.
|
Annexure I
|
JOB RESPONSIBILITY
|
QA/030/F01-00
|
8.0
|
ABBREVIATIONS
|
Abbreviations
|
Full Forms
|
|||||||||
SOP
|
Standard Operating
Procedure
|
|||||||||
QA
|
Quality Assurance
|
|||||||||
9.0
|
DISTRIBUTION
|
|||||||||
Master Copy
|
Head Quality Assurance
Department
|
|||||||||
Controlled office Copy No. 1
|
Head Quality Assurance Deptt.
|
|||||||||
10.0
|
REVISION
HISTORY
|
|||||||||
S.No.
|
Revision
No.
|
Effective
Date
|
Reason for
Revision
|
Details of
Change
|
Authorized
By
(sign
& Date)
|
|||||
Annexure I
JOB PROFILE
CONCERN DEPARTMENT
|
Sr.No.
|
NAME
|
DESIGNATION
|
JOB RESPONSIBILITIES
|
SIGNATURE
|
Authorized
By
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