Team Lead - Quality Assurance

Soterius Life Sciences; Dadri; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Soterius Life Sciences is seeking an experienced QA professional to lead quality assurance activities across the organization in Uttar Pradesh. The role focuses on ensuring regulatory compliance across operations, IT, and processes, while supporting audits, trainings, and continuous improvement initiatives.

You will mentor staff and drive documentation standards through SOPs and quality systems. The ideal candidate has 6+ years in QA, strong regulatory knowledge, and proven ability to work

Qualifications

• More than 6 years of QA experience.
• Experience in team management, training and mentoring personnel.
• Knowledge of regulatory requirements of key regulatory authorities.
• Ability to work independently with minimal supervision.
• Strong communication and time management skills.

Responsibilities

• Implementation and management of QA processes across organization, including regulatory, IT and operations domains.
• Support ongoing compliance with quality and regulatory requirements.
• Assist continuous process improvements.
• Collaborate with internal and external stakeholders to ensure compliance with agreements and guidelines.
• Own assigned projects to ensure timelines and quality standards.
• Train and mentor personnel as needed.
• Author and review SOPs and relevant documents.

Skills

QA leadership

Team management

Regulatory knowledge

Independent work

Communication

Education

Graduate/PG in science or health care

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.
• Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidelines.
• Ensure compliance with the assigned projects including, but not limited to, operational, regulatory and IT Domains. The role will also be responsible for supporting training and audits/inspections.
• Management of quality, compliance and documentation across assigned projects.
• Support department/function during audit/inspection.
• Identify new training and development requirements relevant to the functions.
• Respond to/represent department/ function during audits and inspections, as needed.
• Have ownership of assigned projects and tasks to ensure adherence to timelines and quality standards.
• Train and mentor personnel, as needed.
• Author and review SOPs and other documents relevant for department/ function, as needed.

Required Skills/Experience

• More than 6 years of QA experience.
• Experience in team management, training and mentoring personnel.
• Knowledge of 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, Team Management, cross functional coordination