Senior Quality & Compliance Investigator

SUN PHARMA; Billerica (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

SUN PHARMA in the United States is seeking a Sr. Associate Compliance to support root cause analysis and closure of OOS investigations, OOT investigations, and product quality complaints. You will ensure GLP and cGMP compliance and compile monthly quality metrics for internal and corporate review.

The role involves performing trend analysis, developing CAPAs, and contributing to APQR reports while coordinating with multiple departments to close QMS documents and present findings to QRB meetings.

Qualifications

• Requires BS in chemistry or related scientific field, with strong analytical skills.
• Demonstrated internal and external customer service excellence.
• Ability to manage multiple responsibilities and projects in a fast-paced environment.

Responsibilities

• Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations.
• Work directly on technical investigations relating to Product Quality Complaints.
• Provide verbal and written responses/resolutions to customers regarding product quality complaints or inquiries.
• Participate in other quality investigations and risk assessments as requested to review documents, processes, testing, etc.
• Plan and coordinate routine and non-routine projects requiring independent judgment and compliant techniques.
• Perform statistical analysis of critical attributes and trending of QMS events for each product and provide scientific rationale for conclusions in the APQR.
• Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
• Compile and report on Quality metrics at monthly Quality meetings with trends and recommendations.
• Manage electronic Quality Management System (TrackWise) and implement eQMS, EDMS, LMS with procedures and training.
• Develop monthly QRB meeting presentations based on eQMS and Quality Boards.

Skills

Customer service

Multitasking

Communication

Education

BS in chemistry

Tools

TrackWise

MS Office

SAP

EDMS

LMS

Master Control

Job description

SUN PHARMA in the United States is seeking a Sr. Associate Compliance to support root cause analysis and closure of OOS investigations, OOT investigations, and product quality complaints. You will ensure GLP and cGMP compliance and compile monthly quality metrics for internal and corporate review.

The role involves performing trend analysis, developing CAPAs, and contributing to APQR reports while coordinating with multiple departments to close QMS documents and present findings to QRB meetings.