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Sr. No.
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Job Responsibilities
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1. |
Overview of site QMS documents as per SOP “Overview of Quality Management system documents by CQ” to verify its adequacy and completeness.
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2. |
To prepare a report with appropriate categorizations and scaling of all actionable observations. |
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3. |
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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4. |
Review of site compliance report as applicable and follow ups for adequate closure through appropriate supporting documents from site. |
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5. |
Trend analysis of observation for identification of systemic areas for improvement. |
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6. |
Identify specific areas of improvement based on emerging trends and provide / organize training to the site as and when required. |
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7. |
To prepare monthly reports and participate in departmental meeting. |
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8. |
To present summary of observations to Lead Central Quality (LCQ) / Head Technical Operation (HTO) and management on periodic basis. |
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9. |
To identify and escalate specific issues to management for compliance and support. |
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10. |
To assist in preparation / revision of Corporate SOPs, Guidelines & Policies when required. |
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11. |
Soft copy data management of reviewed documents. |
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12. |
Any additional activity assigned by HOD / Management. |
Source: Zydus Lifesciences careers — Read the original posting and apply
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