Associate Compliance

Sun Pharmaceutical Industries Ltd • Billerica, MA

3d

About The Position

The Associate Compliance supports assessments of Global and site procedures to ensure compliance with current Good Manufacturing Practices (cGMP) and Quality Management System standards. The role compiles monthly Quality metrics for internal and corporate review, analyzes trends, and helps implement corrective and preventive actions to mitigate adverse trends.

The position collaborates with site cross-functional teams and multiple departments on quality investigations, documentation, root cause analysis, risk assessments, and timely QA closure. It manages communication about Global and Billerica site SOPs, supports gap assessments and corporate timelines, and contributes to improvements in procedures and electronic Quality Systems. The Associate Compliance also authors or revises SOPs, prepares materials for monthly Quality and QRB meetings, and provides procedures and training to help employees use electronic Quality Systems effectively.

Requirements

• Bachelor of Science degree in any scientific field.
• Minimum 4–5 years of related experience in a pharmaceutical manufacturing environment.
• Working knowledge of cGMPs and GLPs.
• Strong knowledge of Trackwise for handling electronic Quality Management System (eQMS) data.
• Strong working knowledge of MS Office software.
• Superior internal and external customer service and people skills.
• Ability to manage multiple responsibilities and projects in a fast-paced environment while working efficiently.
• Experience working with cross-functional teams.
• Strong familiarity with the regulatory and compliance environment (cGMP, GLP) associated with parenteral drug manufacture.

Nice To Haves

• Preferably, knowledge of handling EDMS, LMS, Master Control, and Trackwise systems.

Responsibilities

• Support departments with documentation, root cause analysis, and QA closure of Stage II OOS and OOT investigations.
• Participate in other quality investigations and risk assessments, including review of documents, processes, and testing.
• Compile and report Quality metrics at monthly Quality meetings; prepare presentation materials identifying trends and risks and recommending process, procedure, or training changes.
• Manage site-to-corporate communication regarding Global SOPs and Billerica site SOPs.
• Lead meetings and work with site cross-functional teams.
• Drive implementation of gap assessments and meet critical corporate site timelines.
• Apply understanding of Quality systems regulations, CAPA, and change control requirements.
• Manage the electronic Quality Management System (Trackwise).
• Implement electronic Quality Systems, such as QMS, EDMS, and LMS, and provide procedures and employee training for their effective use.
• Develop monthly presentations for QRB meetings based on assessments of Global Procedures, the Quality Matrix, and monthly Quality Investigation Board (QIB) meetings.
• Drive projects to improve Global Procedures for compliance, efficiency, or corporate needs through Trackwise.
• Author or revise standard operating procedures (SOPs) as required.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level