At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. 
Purpose:

The Associate will provide support to the Middleburgh site in all Quality Assurance activities. Closely work with site Quality head to maintain that all aspects of the site operations are conducted using cGMP methodology as well as following all current regulatory guidelines. 

Responsibilities:

• Responsible for supporting management of the Quality System with a focus on continuous improvement and responsibility for ensuring compliance with cGMP, FDA requirements, and internal SOPs.
• Manage Reserve sample programs while adhering to internal procedures.
• Ensure that Annual Product Reviews, SOPs, Change Controls, Complaints, Investigations, CAPAs, Stability Management, IQ/OQ/PQ protocols and reports, and validation protocols and reports are managed in compliance with regulatory requirements.
• Ensures all quality stream documents (change controls, deviations, investigations, etc.) are completed thoroughly and by the required due date.
• Provide general QA Operations support to site activities with focus on documentation review, generation and approval.
• Conduct batch record review and release, change control review and approval, process and analytical investigations, Annual Product Reviews, CAPA follow up etc. related to products manufactured at CPOs to ensure compliance.
• Provide assistance and guidance to Quality Associates.
• Provides data in a timely manner as requested to other departments.
• Assists Site Quality Head during audits and inspections.
• Be continually aware of current industry trends and regulatory agency interpretation of cGMP requirements.
• Responsible to address issues and identify trends that help to ensure compliance, and development and implementation of process improvements.
• Ensures data integrity procedures are in place and effective.
• Conduct internal audits.

Qualifications / Skills:

• BS in Science with Pharmacy or Chemistry as major preferred.
• Minimum of 2 year’s’ experience.
• Will also consider candidates having strong organizational skills, that are familiar with nomenclature commonly associated with Quality and Pharmaceuticals.
• Experience with cloud-based document and training management systems is a plus.