Quality Assurance Executive

AlzaSyno Life Sciences; Gurugram District; On-site; INR 450,000 - 600,000; Full time

Job summary

AlzaSyno Life Sciences is seeking a Quality Assurance Executive for our Gurugram on-site team. You will implement and maintain quality systems to ensure CRO activities, docs, and processes meet internal standards and regulatory requirements.

Responsibilities include reviewing quality-related documents, conducting internal audits, supporting client audits, investigating deviations, and coordinating CAPA. You will collaborate with cross-functional teams across clinical operations, data management,

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.
• Background in Life Sciences disciplines relevant to CRO operations.
• Strong knowledge of GxP (GCP, GLP), ISO standards and regulatory guidelines.
• Excellent attention to detail and strong documentation skills.

Responsibilities

• Review and approve quality-related documents and records.
• Perform internal audits and support external/client audits.
• Investigate deviations and non-conformances; coordinate CAPA actions.
• Monitor adherence to SOPs and regulatory guidelines.
• Collaborate with cross-functional teams across clinical operations, data management, biostatistics, medical writing, and regulatory affairs.

Skills

Quality Assurance

Quality Management

Quality Control

Auditing

Regulatory knowledge

Attention to detail

Documentation skills

Cross-functional collaboration

Education

Life Sciences degree

Job description

Company Description

AlzaSyno Life Sciences is a Contract Research Organization (CRO) providing end-to-end services to pharmaceutical, bio-pharmaceutical, medical device, and Ayurvedic organizations. The company supports clinical operations from Phase 1 to Phase 4, including study design, protocol development, site selection, and regulatory-compliant monitoring. Its data management and biostatistics teams ensure accurate data collection, validation, database design, and statistical analysis for submissions and publications. AlzaSyno also offers specialized medical writing for clinical documentation and regulatory submissions, along with regulatory affairs support to develop strategy, prepare filings, and act as liaison with global regulatory agencies. Professionals joining AlzaSyno contribute to streamlined, compliant clinical research and product development across diverse healthcare sectors.

Role Description

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. Day-to-day responsibilities include reviewing and approving quality-related documents, performing internal audits, supporting external and client audits, and monitoring adherence to SOPs and regulatory guidelines. The role involves investigating deviations and non-conformances, coordinating corrective and preventive actions (CAPA), and supporting continuous improvement initiatives across clinical operations, data management, biostatistics, medical writing, and regulatory affairs. The Quality Assurance Executive collaborates closely with cross-functional teams to promote a culture of quality and operational excellence.

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.
• Background in Food Technology or related life sciences discipline, with the 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, and ability to interpret and apply regulatory and quality requirements in practice.
• Effective communication and documentation skills, with the ability to collaborate across multidisciplinary teams and present quality findings clearly.
• 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.