Pharma Quality Compliance Specialist

SUN PHARMA; Billerica (MA); On-site; USD 75,000 - 110,000; Full time

Job summary

SUN PHARMA is seeking an Associate Compliance to support assessments of Global procedures and site procedures to ensure cGMP and QMS compliance. The role also compiles monthly quality metrics and analyzes trends to drive CAPAs and corrective actions.

Responsibilities include documenting investigations (OOS/OOT), reporting metrics at quality meetings, managing Trackwise-based QMS data, and contributing to SOP development and training.

Qualifications

• BS in any scientific field.
• Superior internal and external customer service/people skills.
• Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner.
• Experience working with cross functional Teams.

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.
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
• Management of site to corporate communication on all of the Global SOPs and Billerica site SOPs.
• Requires excellent communication and organizational skills to lead meetings and work with site cross-functional teams.
• Driving the implementation of gap assessments and meeting critical corporate site timelines.
• Also understanding of the Quality systems regulations and CAPA, change control requirements.
• Understanding of technical writing.
• Manage electronic Quality Management System (Trackwise)
• Implement electronic Quality Systems, such as QMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Develop presentation monthly for QRB meeting based on assessments of Global Procedures, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
• Drive projects to improve the Global Procedures for compliance through Trackwise (TW), efficiency, or corporate needs
• Author/revise standard operating procedures (SOPs) as required
• Other duties as assigned

Skills

Strong communication

Cross-functional collaboration

Quality metrics analysis

Project management

Education

BS in any scientific field

Tools

Trackwise

MS Office

eQMS

EDMS

LMS

Job description

SUN PHARMA is seeking an Associate Compliance to support assessments of Global procedures and site procedures to ensure cGMP and QMS compliance. The role also compiles monthly quality metrics and analyzes trends to drive CAPAs and corrective actions.

Responsibilities include documenting investigations (OOS/OOT), reporting metrics at quality meetings, managing Trackwise-based QMS data, and contributing to SOP development and training.