Quality Systems & Compliance Associate

Sun Pharmaceutical Industries Ltd; Billerica (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Massachusetts seeks an Associate Compliance to support assessments of global and site procedures to ensure cGMP and QMS compliance. You will compile monthly quality metrics, analyze trends, and drive CAPA actions.

The role involves Trackwise eQMS management, cross-functional collaboration, and ensuring timely QA closure of investigations. The position requires strong communication, organizational skills, and experience with regulatory/compliance in parenteral

Qualifications

• BS in a scientific field required.
• 4–5 years in a pharmaceutical manufacturing environment.
• Strong knowledge of cGMPs and GLPs.
• Experience with Trackwise for eQMS data handling.
• Familiarity with EDMS, LMS, Master Control and Trackwise is a plus.
• Regulatory/compliance experience in parenteral drug manufacture.

Responsibilities

• Support multiple departments to close Stage II OOS and OOT investigations with root-cause analysis.
• Participate in quality investigations and risk assessments and review documents and testing.
• Compile and report Quality metrics for monthly meetings and present trends.
• Managing site to corporate communication on Global SOPs and site SOPs.
• Lead cross-functional meetings with strong communication and organization.
• Drive gap assessments and meet corporate/site timelines.
• Understand CAPA, change control requirements and quality system regulations.
• Author or revise SOPs as needed and manage electronic quality systems.

Skills

Customer service

Cross-functional teamwork

Multitasking

Regulatory/compliance knowledge

Communication skills

Education

BS in any scientific field

Tools

Trackwise

EDMS

LMS

Master Control

MS Office

Job description

Sun Pharmaceutical Industries Ltd in Massachusetts seeks an Associate Compliance to support assessments of global and site procedures to ensure cGMP and QMS compliance. You will compile monthly quality metrics, analyze trends, and drive CAPA actions.

The role involves Trackwise eQMS management, cross-functional collaboration, and ensuring timely QA closure of investigations. The position requires strong communication, organizational skills, and experience with regulatory/compliance in parenteral