Associate Manager - QMS Central Quality

**Sr.
No.Job
Responsibilities (QMS-Sterile Injectables) **

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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

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

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

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

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

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

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To
prepare monthly reports and participate in departmental meeting.

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

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To
identify and escalate specific issue to management for compliance and
support.

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To assist
in regulatory and external inspection for site readiness

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To
present summary of observations to management on periodic basis.

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To
participate in periodic central quality audits to laid down quality systems
taking holistic view on the product quality & patient safety; as &
when required.

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To
provide concurrence to the audit observations & compliance as & when
needed.

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To assist
in preparation / revision of Corporate SOPs, Guidelines & Policies when
required.

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Soft copy
data management of reviewed documents.

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Any
additional activity assigned by HOD / Management.