Career Opportunities: Senior Manager - 2 (32036)
Requisition ID 32036 - Posted - ALL - India
Position:
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Senior Manager
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Job Title:
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Job Grade:
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Function:
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Corporate Quality Compliance
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Sub-function:
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Global Actions Management
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Manager’s Job Title:
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Skip Level Manager’s Title:
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Function Head Title:
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Sr. General Manager
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Location:
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Vadodara
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No. of Direct Reports (if any)
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3
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Areas of Responsibility
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- Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action
- Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action
- Ensure assessment of internal learning (such as Quality alert) to derive the global action
- Preparation of Global action based, following are the sub-activities:
- Review of the regulatory guidance related to the topic
- Review of existing site practices
- Drafting of Global action recommendations
- Preparation of reference procedures and associated formats for Global action implementation as applicable
- Finalization of Global action recommendation post review with Global action committee and relevant stakeholders
- Ensure issuance and approving of Global actions in Trackwise.
- Coordinating with sites for the implementation of Global action recommendations
- Ensure review of site action closure for completeness and correctness
- Ensure closure of global action upon completion of all issued site action records of a global action
- Ensure circulation of Global action status to relevant stakeholders
- Ensure compliance calls being executed as per pre-defined agenda i.e. internal and external learnings being shared and explained with stakeholders.
- Ensure identified gaps being shared across sites and tracked for implementation
- Ensure maintenance of database for regulatory inspections at SUN Pharma
- Review of draft response of inspection observation
- Ensure Sun site regulatory inspection observations trend is in place for meaningful analysis
- All other duties as assigned by Head Corporate Quality Compliance and CQA
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Travel Estimate
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Approximate 30%
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Job Scope
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Internal Interactions (within the organization)
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Yes
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External Interactions (outside the organization)
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No
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Geographical Scope
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Financial Accountability (cost/revenue with exclusive authority)
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Job Requirements
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Educational Qualification
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M.SC / M. Pharm
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Specific Certification
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Not specific
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Skills
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Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile)
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Experience
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Minimum 15 years
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