1. Purpose:
1.1. The purpose of this SOP is to describe the procedure
of specific training of QA personnel.
2. Scope:
This SOP is applicable to
Quality Assurance Department.
3. Responsibility:
Quality Assurance Manager
4. Procedure:
4.1. On joining of new personnel to
Quality Assurance Department, QA Manager issues job description (JD) to the
personnel.
4.2.
Specific training program to the new employees (Quality Assurance Officer,
Quality Assurance Inspector/ Quality Assurance Assistant) of quality assurance
department must covers the following aspects
S/N
|
Training
Topic
|
01.
|
Introduction
to Quality Assurance.
|
02.
|
Awareness
on cGMP.
|
03.
|
Introduction
to Quality Audit.
|
04.
|
Market
Complaints and Product Recalls.
|
05.
|
Self-study
of Quality Assurance SOPs.
|
4.3. Specific training must be completed
within two weeks of the joining of new personnel’s.
4.4. Assessment of the new personnel must
be done after the completion of the training program.
4.5. Record of such trainings should be
kept with the Quality Assurance Department.
4.6. Besides the specific training of the
new employee, QA new employee will also receive continuous trainings as per SOP
for the Training of Personnel’s (Ref. # QA/T/01).
5. List
of Recipients:
5.1. Quality Assurance Department.
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