IPQA Associate

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.

In‑Process Quality Assurance (IPQA) | Onsite

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.

• 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 Track Wise.
• 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.

This role operates within a combination of manufacturing, laboratory, and office environments. The position requires regular interaction with production operations and quality systems to ensure compliance and product quality.

The work environment may include:

• Manufacturing and packaging operations
• Laboratory and warehouse areas
• Moderate noise levels
• Routine use of personal protective equipment (PPE)

• Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, and reach throughout the workday.
• Ability to lift and carry up to 25 pounds.
• Ability to navigate office, laboratory, warehouse, and manufacturing environments.
• Must be able to wear required PPE, including respirators, safety glasses, goggles, and safety shoes.

Travel:
Up to 5%

• Bachelor's degree in a science‑related major required.

• Understanding of cGMP regulations and pharmaceutical quality systems.
• Experience with electronic quality systems such as Track Wise or similar QMS platforms.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook.
• Familiarity with SAP and Learning Management Systems (LMS) is beneficial.
• K…