Associate, Quality Assurance (QMS)

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Role Description:

• The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site.
• This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.

Responsibilities:

• Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.
• Support the preparation and tracking of quality metrics and trending reports.
• Help coordinate internal audits and document audit responses.
• Participate in documenting product quality complaints and adverse event records.
• Aid in digitizing logbooks and checklists using electronic systems.
• Collaborate with cross-functional teams to ensure timely and accurate documentation updates.
• Provide administrative support for change control processes and quality-related meetings.
• Assist in preparing documentation for regulatory inspections and external audits.
• Maintain document control systems and ensure timely review and archival of QA records.
• Support training documentation and tracking for QA-related procedures.
• Help with data entry and analysis for quality reports using basic statistical tools.
• Monitor document lifecycle and ensure version control compliance.
• Participate in continuous improvement initiatives related to documentation and QMS processes.

Requirements:

Education & Experience

• Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.
• Preferred Education: Master’s degree is a plus.
• Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).
• Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.

Physical Requirements

• On-site role at Chestnut Ridge, NY.
• Standard work hours: 8 AM to 5 PM.
• No travel required.
• No lifting or driving responsibilities.