Senior Manager 1
Year Vadodara, Gujarat, India
Job Description
Job Summary: Responsible for regulatory inspection observation assessment for Inspections at SUN sites, issuance of Global actions, initiation for Global compliance activities based on performed assessment. Essential Job Functions:
- Assessment of regulatory inspection observation for identification of,
- Category I citation- Requirement of Global Action
- Category II & III citation- To be shared for site reference
- Preparation of Global action based on Category I citations, following are the sub-activities:
- Review of the regulatory guidances 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
- Discussion of draft Global action recommendation with relevant stakeholder
- Issuance of Global actions in Trackwise.
- Coordinating with sites for the implementation of Global action recommendations
- Review of draft response of inspection observation (As and when required)
- Review of draft site procedures (SOPs/ protocols/ reports etc.) related to issued Global actions (As and when required)
- Review of site action closure
- Preparation of Inspection observation assessment report
- Preparation and circulation of Global action status to relevant stakeholders
- Maintaining database for regulatory inspections at SUN Pharma
- To perform any additional activities allotted by reporting manager.
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Job Detail
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Job IdJD2995863
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationVadodara, Gujarat, India
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EducationNot mentioned
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ExperienceYear