Research Associate II (Stability)

Location: Ahmedabad, Gujarat, India; onsite

Company

hirify.global develops healthcare products and solutions guided by its mission to save and sustain lives.

What you will do

• Develop, plan, and execute stability study designs for new product development and sustaining product projects.
• Independently select analytical techniques, evaluate results, and resolve routine and non-routine experimental design problems.
• Provide technical rationale for expiration dating and label storage recommendations.
• Prepare regulatory submissions, respond to regulatory communications, and complete compliance deliverables on schedule.
• Collaborate with QA, M&Q, Regulatory, Quality Control, and project stakeholders to advance research and development activities.
• Lead analytical problem-solving, process improvement, operational excellence, change controls, NCR/sNCR handling, and SOP implementation.

Requirements

• In-depth knowledge of cGxP regulations and relevant stability-related ICH guidelines.
• Ability to design stability studies, apply scientific theories and principles, and assess results for validity and compliance with specifications.
• Experience using LIMS for electronic stability protocols and applying appropriate research techniques and procedures.
• Ability to manage complex, multi-variable technical tasks and coordinate cross-functional stakeholders within agreed deadlines.
• Work is based onsite in Ahmedabad, Gujarat, India.

Culture & Benefits

• Work is guided by a mission to save and sustain lives.
• Culture emphasizes courage, trust, collaboration, ownership, and accountability.
• Equal employment opportunity and reasonable accommodations are provided.