Associate Manager - QMS Injectable

Zydus Lifesciences; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Job summary

Zydus Lifesciences is seeking a QA/QMS Associate for the Sterile Injectables unit. The role focuses on reviewing site QMS documents for adequacy and completeness, evaluating deviations, investigations, change controls, equipment and utilities qualification, process validation, APQR, and QMS trend reports.

The incumbent will prepare actionable observations, discuss gaps with QA leadership, and support regulatory readiness.

Responsibilities

• Overview of site QMS documents as per SOP to verify adequacy and completeness.
• Review Deviations and assess impact.
• Review Process Investigations (OOS-Phase II).
• Review Change controls.
• Review Qualification (Equipment and Utilities).
• Review Process validation.
• Review APQR (Annual Product Quality Review).
• Review QMS Trend reports.
• Prepare a report with appropriate categorizations and scaling of all actionable observations.
• Discuss gaps identified during review with site SME / QA Head / Lead Central Quality (LCQ) / Head Technical Operation (HTO) for resolution.
• Review site compliance reports and ensure closure through supporting documents.
• Perform trend analysis of observations to identify systemic areas for improvement.
• Identify areas for improvement based on emerging trends and organize training.
• Prepare monthly reports and participate in departmental meetings.
• Present summary of observations to LCQ / HTO and management periodically.
• Identify and escalate specific issues to management for compliance support.
• Assist in regulatory and external inspections for site readiness.
• Present summaries to management periodically.
• Participate in periodic central quality audits to ensure quality systems and patient safety.

Job description

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 ELEMENTS TO BE REVIEWED INCLUSIVE OF :

• Deviations
• Process Investigations (OOS-Phase II)
• Change controls
• Qualification (Equipment and Utilities )
• Process validation
• APQR
• QMS Trend reports

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 elevate 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.