IPQA Associate I

About the role

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. We are seeking a detail-oriented and quality-focused IPQA Associate I to support in-process quality assurance activities across our pharmaceutical manufacturing operations. In this role, you will be responsible for monitoring manufacturing and packaging activities, ensuring compliance with cGMP requirements, SOPs, and quality standards, while helping to identify and address quality issues before they impact product integrity. This is an excellent opportunity for a quality professional who enjoys collaborating cross-functionally, working directly on the production floor, and playing an active role in maintaining product quality and regulatory compliance. The position requires up to 5% travel.

Responsibilities

• Perform routine area assessments to ensure compliance with cGMP requirements, SOPs, policies, and procedures.
• Provide line clearance authorization prior to manufacturing and packaging operations.
• Conduct conditional and final release inspections of packaging lines.
• Support and monitor in-process quality checks during manufacturing and packaging activities.
• Collaborate with Production and Packaging teams to resolve quality-related issues and ensure compliance throughout operations.
• Perform retain sample inspections as required.
• Support stability sample collection and submission to the Quality Control laboratory.
• Verify AQL (Acceptable Quality Level) inspections during batch manufacturing and packaging operations.
• Review and approve controlled documents, including manufacturing and packaging batch records.
• Ensure timely and accurate completion of quality-related documentation.
• Support the closure of immediate actions within TrackWise.
• Manage material status and compliance-related transactions within SAP.
• Review cleaning validation protocols and reports.
• Review process validation protocols and reports.
• Support Annual Product Review (APR) data entry and compilation activities as needed.
• Assist with quality improvement initiatives, remediation projects, and other QA-related activities.
• Maintain ownership and accountability for assigned QA processes and projects.
• Provide support across multiple New Jersey facilities as business needs require.
• Partner with Manufacturing, Packaging, Validation, and Quality teams to drive compliance and continuous improvement.

Requirements

• Education: Bachelor's degree in a science related major required.
• Technical Skills & Knowledge:
  • Understanding of cGMP regulations and pharmaceutical quality systems.
  • Experience with electronic quality systems such as TrackWise or similar QMS platforms.
  • Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook.
  • Familiarity with SAP and Learning Management Systems (LMS) is beneficial.
  • Knowledge of project management principles, practices, and tools.
  • Ability to review and interpret validation documentation and manufacturing records.
• Professional Skills:
  • Strong organizational and time management skills with the ability to manage multiple priorities.
  • Excellent verbal and written communication skills.
  • Strong attention to detail and problem-solving abilities.
  • Ability to work effectively both independently and within cross-functional teams.
  • Self-motivated with a hands-on, proactive, and solution-oriented approach.
  • English language proficiency at CEFR Intermediate B1+ level.
• Experience:
  • Minimum 2 years of experience in a pharmaceutical quality role.
  • Experience supporting manufacturing, packaging, quality assurance, or quality systems activities in a regulated environment.
  • Experience working in a global, matrixed, or multicultural organization is preferred.

Benefits

• Play a critical role in ensuring the quality and compliance of pharmaceutical products.
• Gain