Associate/ Sr Associate - Quality Assurance

Soterius Life Sciences; Dadri; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Soterius Life Sciences is seeking a QA/QA Compliance professional to drive quality assurance processes and ensure regulatory compliance across operations, regulatory and IT domains from its Dadri (Uttar Pradesh) base. The role emphasizes ownership of projects, audits, and continuous process improvements.

The candidate should have strong pharmacovigilance knowledge, work independently, and excel in communication and time management to coordinate with internal and external stakeholders.

Qualifications

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

Responsibilities

• Implementation and Management of Quality Assurance processes and ensuring compliance across the organization including operational, regulatory and IT domains.
• Support ongoing compliance with quality and industry regulatory requirements.
• Provide support during continuous process improvements.
• Ownership of 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.
• Support department/function during audit/inspection.

Skills

Pharmacovigilance knowledge

Independent work

Communication & time mgmt

Education

Science/Healthcare degree

Job description

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.
• Provide support during continuous process improvements.
• 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.
• Support department/function during audit/inspection.

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