Associate Manager - QMS Central Quality

Sr. No.

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.
• To identify and escalate specific issue to management for compliance and support.
• To assist in regulatory and external inspection for site readiness To present summary of observations to management on periodic basis.
• To participate in periodic central quality audits to laid down quality systems taking holistic view on the product quality & patient safety; as & when required.
• To provide concurrence to the audit observations & compliance as & when needed.
• To assist in preparation / revision of Corporate SOPs, Guidelines & Policies when required.
• Soft copy data management of reviewed documents.
• Any additional activity assigned by HOD / Management.