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.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).