Sr. No.
Responsibilities
1.0
Handling of Overall QMS (Quality Management System) activities
1.1
Change Management
1.1.1
Initiation of Change control for QMS related changes, implementation and closure.
1.1.2
Handling of Product Discontinuation Form & log and Support in Initiation of Change control.
1.1.3
Review of Change control details & review of supporting documents on Change control initiation, Allocation & documenting Change control Number, Coordinating all stake holder for impact assessment, to identify the risk association with change, to classify the change control.
1.1.4
Intimation of change control to concern(s) with list of action items, review of change implementation, closure of change control as per TCD and verification of Change implementation effectiveness.
1.1.5
Follow up on Change control for timely assessment, approval, extension & amendment (if required), closure and effectiveness with documenting all necessary supporting evidences.
1.1.6
Updation and maintain Change control log / register.
1.2
Deviation Management
1.2.1




Initiation of Deviation for QMS related changes, implementation and closure.
1.2.2
Review of deviation details & review of supporting documents on deviation initiation, Allocation & documenting Deviation Number, Coordinating all stake holder for impact assessment, to identify the risk association, review of investigations, to classify the deviation, to check the past history of similar deviation.
1.2.3
Intimation of deviation to concern(s) with list of action items, review of CAPA implementation, closure of deviation and verification of effectiveness check. Review of Plant Breakdown maintenance documents.
1.2.4
Follow up on deviation for timely assessment, approval, extension (if required), closure and effectiveness with documenting all necessary supporting evidences.
1.2.5
Updation and maintain deviation log / register.
1.3
Handling of Investigations
1.3.1
To investigate any non-conformance resulted against compliance of GxP and

📌 Sr. Officer-QA QMS (Ahmedabad)
🏢 Troikaa Group
📍 Ahmedabad