Senior Manager - Corporate Quality Compliance

Position

Senior Manager

Sub-function

Global Actions Management

Function

Corporate Quality Compliance

Function Head Title

Sr. General Manager

Location:

Vadodara

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:
  
  

v. Review of the regulatory guidance related to the topic

vi. Review of existing site practices

vii. Drafting of Global action recommendations

viii. Preparation of reference procedures and associated formats for Global action implementation as applicable

ix. 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 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