Sr. Officer-QA QMS

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 to identify the root cause.

1.3.2

To review investigation report reference to any non-conformance of GxP.

1.3.3

Intimation and Initiation of CAPA based on outcome of Investigation, Verification of CAPA implementation and Closure.

1.4

CAPA Management

1.4.1

Initiation of CAPA for QMS related actions, implementation and closure.

1.4.2

Review of CAPA details & review of supporting documents on CAPA initiation, Allocation & documenting CAPA Number.

1.4.3

Intimation, Coordination & Follow up of CAPA to concern(s) with list of action items, review & closure of CAPA, extension (if required), review of CAPA implementation and verification of effectiveness check with documenting all necessary supporting evidences.

1.4.4

Updation and maintain CAPA log / register.

1.5

Handling of Market Complaint

1.5.1

Receiving of Market complaint form from CQA, Allocation & documenting Market complaint Number.

1.5.2

Investigation and Identification of root cause for market complaint, Intimation and Initiation of CAPA based on outcome of Investigation, Verification of CAPA implementation and Closure of Market Complaint.

1.5.3

Updation and maintain Market complaint log / register.

1.6

Handling of Product Recall

1.6.1

Initiation, Intimation of Recall of marketed products, Coordination with Distribution Team, Marketing Team, Officials and Management, Reconciliation & Disposition of recall product.

1.6.2

Execution of Mock trial test for domestic and export market.

1.6.3

Updation and maintain Product recall log / register.

1.7

Preparation of Management Review and Notification

1.7.1

Scheduling, compiling and discussion on Overall Quality system in Management Review Meeting in Plant.

1.8

Risk Management

1.8.1

Initiation, Review and Performing Risk assessment for identified risk factors. To assess the risk, impact and define CAPA, follow up of CAPA implementation and closure within timeframe.

1.8.2

Handling of Risk assessment of Facility, Product, Process, Material, Vendor, etc.

1.8.3

Allocation of Risk assessment No., Updation and maintain Risk Assessment log / register.

1.9

Management of Self inspection Programme

1.9.1

Preparation of Self inspection Annual calendar, Auditor list, coordination in conducting self-inspection audit, Preparation of audit report, review of CAPA proposal & implementation of each observation, Preparation of Audit summary report and Closure report

1.9.2

Perform Audit as a self-inspection auditor as per schedule and verify the compliance of various activities

1.10

Handling of Site Master File, Quality Manual & Laboratory Information File

1.10.1

Preparation, review and Updation of Site Master File & Quality Manual and all supporting Annex(s) of Site Master File & Quality Manual, Handling of Laboratory Information File.

1.11

Management of OOT (Out Of Trends Results)

1.11.1

Review of OOT details & review of supporting documents of OOT initiation, Allocation & documenting OOT Number.

1.11.2

Intimation, Coordination & Follow up of OOT to concern(s) with list of action items, review & closure of OOT, review of CAPA implementation and verification of effectiveness check with documenting all necessary supporting evidences.

1.11.3

Updation and maintain OOT log / register.

1.12

Review of OOS (Out of Specifications Results)

1.12.1

Review of OOS details & review of supporting documents of OOS on initiation of CAPA for OOS closure.

1.12.2

Intimation, Coordination & Follow up of OOS to concern(s) with list of action items, review & closure of OOS, review of CAPA implementation and verification of effectiveness check with documenting all necessary supporting evidences.

2.0

Audit Management

2.1

Involvement on all Audit and Coordination with Auditor.

2.2

Responsible for audit compliance and Preparation of audit response.

3.0

SOP Management

3.1

Preparation and Review of SOP and Annex(s).

4.0

Submission of Documents as per Regulatory Requirement.

5.0

Performs activity of Reviewer Qualification as per SOP.

6.0

Preparation and Review of QMS Trend analysis report.