Manager - Remediation

Job Description

Job Title: Sr. Manager Remediation

Function: Global Quality & Compliance Sub-function:

Manager s Job Title: Head Remediation

Location: Baroda (the role involves frequent travel)

Areas of Responsibility:

• Establish road map for the remediation activities
• Assure timely resolution of issues/risks on remediation projects
• Facilitate preparation for Executive Steering Committee reviews
• Identify and list key activities for implementation, assign activity owners and target completion dates
• Act as the point of contact and communicate remediation status adequately to all team members
• Review the completed remediation actions for their adequacy and ensure it meets the agreed commitment
• Ensuring that key stakeholders are informed on relevant risks and implementing remediation plans
• Candidate needs to be dynamic with good communication and leadership qualities
• Performs all work in line with Sun Pharma values of Humility, Integrity, Passion and Innovation. Performs all work in accordance with all established regulatory and compliance and safety requirement

Education and Experience:

B. Pharm / M. Pharm

Experience of around 15 years in Pharma Industry

Strong understanding of GMP requirements, exposure to Regulatory Inspection, and knowledge of international GMP requirements

Experience in investigations related to complaint, product rejection, non-conformances, recalls, deviations, audits, regulatory inspections etc.

Change management, quality risk management and Corrective Action and Preventive Action System throughout the Product Lifecycle

Implementation and maintenance of effective QMS

Important note: The role involves frequent travel to site locations across India and may require the incumbent to be stationed at other location for few weeks at a time.