Wednesday, 12 October 2016

STANDARD OPERATING PROCEDURE FOR SPECIFIC TRAINING OF PERSONNEL’S (QAD)

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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