Senior Compliance Specialist, Pharmaceutical Quality

Sun Pharmaceutical Industries, Inc.; Billerica (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc (USA) seeks a Sr. Associate Compliance to provide scientific support for root cause analysis and closure of OOS and OOT investigations and product quality complaints. You will ensure GLP and cGMP compliance and contribute to the Quality Management System.

You will compile monthly quality metrics, analyze trends, and implement CAPAs to mitigate adverse trends, while maintaining TrackWise documentation and QA processes across the site.

Qualifications

• BS in chemistry or related scientific field.
• Superior internal and external customer service/people skills.
• 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 product inquiries.
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques.
• Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome.

Education

BS in chemistry or related scientific field

Tools

TrackWise

EDMS

LMS

SAP

Master Control

Job description

Sun Pharmaceutical Industries, Inc (USA) seeks a Sr. Associate Compliance to provide scientific support for root cause analysis and closure of OOS and OOT investigations and product quality complaints. You will ensure GLP and cGMP compliance and contribute to the Quality Management System.

You will compile monthly quality metrics, analyze trends, and implement CAPAs to mitigate adverse trends, while maintaining TrackWise documentation and QA processes across the site.