Associate/ Senior Associate - Quality Assurance

Soterius, Inc.; Dadri; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Soterius, Inc. in Noida is seeking an Associate/Senior Associate in Quality Assurance to lead and uphold QA standards across operational, regulatory and IT domains.

The role involves implementing QA processes and ensuring compliance within a fast-paced health care environment. You will support training and audits/inspections, maintain strong stakeholder relationships, and own assigned projects to ensure timelines and quality expectations are met.

Qualifications

• Knowledge of pharmacovigilance and regulatory requirements.
• Ability to work independently with minimal supervision.
• Strong communication and time management skills.

Responsibilities

• Implement and manage QA processes across operations, regulatory and IT domains.
• Support training, audits and inspections.
• Ensure compliance with quality and regulatory requirements.
• Own assigned projects to meet timelines and quality standards.

Skills

Pharmacovigilance

Regulatory knowledge

Independent work

Communication skills

Education

Graduate/Postgraduate in scientific or health care

Job description

Associate/ Senior Associate - Quality Assurance

0-4

Noida

Full-Time

Key Responsibilities

• Implementation and Management of Quality Assurance processes and ensuring compliance across the organization including, but not limited to, operational, regulatory and IT Domains. The role will also be responsible for supporting training and audits/inspections.
• Support ongoing compliance with quality and industry regulatory requirements.
• Have ownership of the assigned projects and tasks to ensure adherence to timelines and quality standards.
• Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidelines.

Required Skills/Experience

• Knowledge of pharmacovigilance and regulatory requirements of key regulatory authorities.
• Ability to work independently with minimal supervision.
• Strong communication and time management skills.

Educational Requirements

• Graduate, Postgraduate, 4-years college degree or equivalent, in a scientific or health care discipline.

Recommended Keywords

• GVP, Audits and Inspection, CSV, GAMP, Deviation Management, Change Control, RCA