1.0 PURPOSE :
To Execute responsibilities for the QA Manager.
2.0 SCOPE :
To impart duties and responsibilities for the QA Manager.
3.0 RESPONSIBILITIES :
Applicable to QA Manager.
4.0 procedure :
4.1 Implementation of Quality Assurance System.
4.2 Checking of Master Documents
4.3 Authorise Batch manufacturing records
4.4 Batch record review and finished product release
4.5 To Co-Ordinate validation activity and prepare validation protocols.
4.6 To control and approve deviations in the production and record the deviations.
4.7 Preparation and authorization of standard operating and cleaning procedure
4.8 Preparation for various audits to be carried out by external organisations.
4.9 To plan and carryout Internal audits.
4.10 To Co-Ordinate with Q.C./Production for handling and investigation of Market complaints.
4.11 To check and approve art works in co-ordination with QC / Packaging Department /Commercial Department/Production Department.
4.12 To revise and upgrade Q.A System.
4.13 Responsible for conducting ongoing training programs for new recruits and retraining for existing employees.
4.14 Responsible for improvement in quality of the product by encouraging and motivating people on the shop floor by counselling and guidance.
4.15 As a site Q.A. Manager should have better co-ordination with Production, Q.C. and Maintenance for implementation of CGMP.