Senior Associate, Compliance

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

The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.

Area Of Responsibility

• 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 of the conclusion presented 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, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
• Manage electronic Quality Management System (TrackWise)
• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
• Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
• Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
• Author/revise standard operating procedures (SOPs) and test methods, as required
• Other duties as assigned

Work Conditions:

• Office

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
• Talk or hear
• Close vision
• Computer/office machines
• Lift up to 10 lbs.

Some travel outside of company facility required

• Up to 5%

Education and Job Qualification

• 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, while performing in an efficient manner

Experience

• Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
• Working knowledge of cGMPs, GLPs
• Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
• Strong knowledge of instrumental and wet analytical chemistry
• Strong knowledge of microbiology testing
• Strong working knowledge of MS Office software
• Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc…
• Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
• Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture