Associate Manager - QMS Central Quality

Sr. No.

Job Responsibilities (QMS-Sterile Injectables)

-

Overview of site QMS documents as per SOP “Overview of Quality Management system documents by CQ” to verify its adequacy and completeness.

QMS ELEMNETS TO BE REVIEWED INCLUSIVE OF :

• Deviations

• Process Investigations (OOS-Phase II)

• Change controls

• Qualification (Equipment and Utilities )

• Process validation

• APQR

• QMS Trend report’s

-

To prepare a report with appropriate categorizations and scaling of all actionable observations.

-

To discuss the gaps identified during review with site SME / QA Head / Lead Central Quality (LCQ) / Head Technical Operation (HTO) for resolution.

-

Review of site compliance report as applicable and follow ups for adequate closure through appropriate supporting documents from site.

-

Trend analysis of observation for identification of systemic areas for improvement.

-

Identify specific area of improvement based on emerging trend and provide / organize training to the site as and when required.

-

To prepare monthly reports and participate in departmental meeting.

-

To present summary of observations to Lead Central Quality (LCQ) / Head Technical Operation (HTO) and management on periodic basis.