About the role
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.
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.