Quality Assurance Executive

About the Role

The Quality Assurance Executive is a full-time, on-site role based in Gurugram. This position is responsible for implementing and maintaining quality systems to ensure that all CRO activities, documentation, and processes comply with internal standards, regulatory requirements, and client specifications. The Quality Assurance Executive collaborates closely with cross-functional teams to promote a culture of quality and operational excellence.

Key Responsibilities

• Reviewing and approving quality-related documents.
• Performing internal audits.
• Supporting external and client audits.
• Monitoring adherence to SOPs and regulatory guidelines.
• Investigating deviations and non-conformances.
• Coordinating corrective and preventive actions (CAPA).
• Supporting continuous improvement initiatives across clinical operations, data management, biostatistics, medical writing, and regulatory affairs.

Requirements & Tech Stack

• Background in Food Technology or related life sciences discipline.
• Ability to apply scientific and regulatory concepts to CRO operations.
• Strong knowledge of GxP (such as GCP, GLP), ISO, ISMS, DPDP, clinical research regulations, and industry guidelines relevant to pharmaceuticals and medical devices.
• Excellent attention to detail.
• Analytical skills.
• Ability to interpret and apply regulatory and quality requirements in practice.
• Effective communication and documentation skills.
• Ability to collaborate across multidisciplinary teams.
• Ability to present quality findings clearly.

Qualifications

• Demonstrated proficiency in Quality Assurance and Quality Management, including implementation and oversight of quality systems and SOPs.
• Hands-on experience in Quality Control activities to verify data, processes, and documentation against defined standards.
• Experience in Quality Auditing, including planning, conducting, and documenting internal audits and supporting external/client audits.
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Food Technology, Biotechnology, or a related field.
• Prior experience in a CRO or regulated healthcare environment is an advantage.