Title:  Senior Manager 2 - Compliance & Internal Audits

Position:

Senior Manager 2

Job Grade:

G9B

Job Title:

Senior Manager - Compliance and Internal Audit

Sub-function:

Compliance and Internal Audit

Function:

Quality

Skip Level Manager’s Title:

Vice President – Head Cluster Quality II & III

Manager’s Job Title:

Sr. General Manager - Quality Head

Location:

Sun Pharma, Mohali

Function Head Title:

Sr. General Manager - Quality Head

No. of Direct Reports (if any)

1

Responsible for overall compliance and internal audit function at site. Facilitate for all time readiness of the site through internal audits, ensuring regulatory agency audits\inspections readiness at any given point of time with appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams. Monitor and track quality assurance/control metrics with site manufacturing and other cross functions.

Areas of Responsibility

• Responsible for monitoring of all cGMP activities at site.
• Facilitate review and support regulatory inspection management.
• Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits.
• Prepare, facilitate and ensure timely inspection response and monitor CAPA timelines.
• Collaborate with Corporate compliance group and implement global CAPA.
• Facilitate, review and monitor cross functional investigation teams.
• Support plant for management of compliance activities.
• Regularly evaluate and report compliance status of site to Site Quality Head.
• Support for major health authority inspections at site and provide input and support to inspection responses to drive consistency and clarity at the site.
• Responsible for approval of investigation plan to proceed for investigation.
• Support compliance investigations as needed in collaboration with others at site.
• Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
• Provide support in execution and monitoring of remediation compliance through compliance

verification audits.

• Responsible for overall compliance and bringing solutions to compliance related issues within the site.
• Review Regulatory inspection observations, trend and decide compliance strategy.
• Educate and institutionalize a culture of Quality and compliance at the site.
• Responsible for conducting self-inspection (Internal Audits) for all quality systems & sub systems at the site and responsible for Internal Audit management at site in accordance with established SOPs & SUN Pharma Global Quality Policy/ Standards.
• Lead internal quality audit team/ cross functional internal audit teams at site to ensure & monitor overall audit compliance to SUN Pharma’s internal standards & cGXP requirements.
• Responsible for preparing, maintaining & approving of annual internal audit schedule. Updating of the Internal audit log & assign an internal audit tracking number.
• Responsible for preparation of audit strategy documents & sharing with auditee department prior or on the day of audit. Tracking & follow ups of open action item to timely close the internal audit observation.
• Prepare & maintain a list of Qualified Auditors as per the requirements listed in Internal Audit SOP.
• Responsible for review of audit response, closure of audit & issuance of audit closure report once all audit observations have been closed.
• Collaborate with corporate audit group & facilitate Corporate Audits at site.
• Coordinate & support of major regulatory/ health authority inspections at site & provide input & support to inspection responses to drive consistency & clarity across organization.
• Responsible for sharing audit reports, classification of each audit observation, escalation of any critical & major observations to site management team & to provide recommendations for corrective action & preventive action, if any.
• Responsible for verification of compliance status of previous audit observation in next audit.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.

Travel Estimate

N/A

Job Scope

Internal Interactions (within the organization)

All Department Head

External Interactions (outside the organization)

Corporate & Cluster Quality, Consultants, Regulatory / Customer Inspector.

Geographical Scope

North India

Financial Accountability (cost/revenue with exclusive authority)

N/A

Job Requirements

Educational Qualification

M. Sc. / M. Pharma or B Pharma

Specific Certification

Auditor Certification

Skills

Auditing, Investigator, Data Integrity Expert

Experience

Min. 15 Years

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).