Quality Assurance & Compliance Associate II

Sun Pharmaceutical Industries, Inc.; New Brunswick, Northern (NJ, KY); Hybrid; USD 74,000 - 83,000; Full time

Job summary

Sun Pharma is seeking a highly motivated Compliance Associate II to support and strengthen our Quality Management System (QMS) and site compliance programs. This role maintains regulatory compliance, drives quality system effectiveness, and supports inspection readiness in accordance with cGMP requirements.

You will independently manage quality system processes such as Deviation Management, Change Control, and Cleaning Validation, while collaborating with cross-functional teams to promote

Qualifications

• Bachelor's degree required.
• Experience with Quality Management Systems (QMS) and quality event management.
• Strong knowledge of cGMP regulations, quality systems, and pharmaceutical compliance requirements.

Responsibilities

• Independently manage and perform preliminary assessments for deviations within TrackWise.
• Independently review and manage change controls and facilitate CRB meetings.
• Monitor deviation and change control lifecycles for timely investigations and closures.
• Collaborate with cross-functional teams to drive quality events to completion and maintain compliance.
• Ensure compliance with ALCOA+ data integrity principles across investigations and GMP records.

Skills

TrackWise

ALCOA+

cGMP

Change Control

Deviation Mgmt

Cleaning Validation

QMS

Data Integrity

Inspection Readiness

FDA Inspections

Education

Bachelor's Degree

Tools

LMS

MS Office

Data analysis tools

Job description

Sun Pharma is seeking a highly motivated Compliance Associate II to support and strengthen our Quality Management System (QMS) and site compliance programs. This role maintains regulatory compliance, drives quality system effectiveness, and supports inspection readiness in accordance with cGMP requirements.

You will independently manage quality system processes such as Deviation Management, Change Control, and Cleaning Validation, while collaborating with cross-functional teams to promote