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Senior Manager - DSRM

Senior Manager - DSRM

Lupin

14 - 21 years

25 - 30 Lacs

Mumbai

Posted:1 month ago| Platform:

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Skills Required

Quality improvement Manager Quality Assurance Internal audit Pharmacy Trend analysis Process excellence Inspection Pharmacovigilance Stakeholder management Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

To develop risk-based and Pharmacovigilance (PV) audit program and execute the same within stipulated timelines. To support implementation of the quality strategy, plans for quality improvement and quality assurance initiatives. To prepare for audits and conduct PV internal audits and audits of business partners/ vendors as applicable. To support hosting of Health Authority inspections and external partner audits. To obtain audit responses from internal PV team/subsidiaries and external partners/vendors and evaluate proposed corrections, CAPA for adequacy and appropriateness. Escalate inadequate audit responses to management. To maintain tracker for audit and inspection findings and track compliance for timely completion of Corrective and Preventive Action. To assign Non-Conformances (NC) and Corrective and Preventive Action (CAPA) numbers and review NC information against source documents. To review CAPA implementation documents against source documents and provide feedback on CAPA effectiveness. To ensure that NC/CAPA tracker is maintained as per SOP for inspection readiness and documents are updated. To conduct and close CAPA effectiveness. To support trend analysis of deviations to identify risk areas. To manage, review, tracking and closure of Change Control Requests (CCRs)

Work Experience

Minimum 10 years in PV of which at least 4 years in QA.

Education

Graduation

Post Graduation in Science or Pharmacy

Competencies

Innovation & Creativity

Process Excellence

Developing Talent

Stakeholder Management

Strategic Agility

Collaboration

Result Orientation

Customer Centricity

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Pune

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Senior Manager - DSRM