Job Information
Sun Pharmaceuticals, Inc Senior Manager - 2 in India
Position:
Senior Manager
Job Title:
Job Grade:
Function:
Corporate Quality Compliance
Sub-function:
Global Actions Management
Managers Job Title:
Skip Level Managers Title:
Function Head Title:
Sr. General Manager
Location:
Vadodara
No. of Direct Reports (if any)
3
Areas of Responsibility
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
Travel Estimate
Approximate 30%
Job Scope
Internal Interactions (within the organization)
Yes
External Interactions (outside the organization)
No
Geographical Scope
Financial Accountability (cost/revenue with exclusive authority)
Job Requirements
Educational Qualification
M.SC / M. Pharm
Specific Certification
Not specific
Skills
Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile)
Experience
Minimum 15 years
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Sun Pharmaceuticals, Inc
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