Team Lead - Quality Assurance

Soterius, Inc.; Dadri; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Soterius, Inc. in India is seeking a Quality Assurance leader with 6+ years' QA experience to implement and manage QA processes across operations, regulatory and IT domains.

You will train and mentor staff, handle audits and inspections, prepare SOPs, and ensure adherence to timelines and quality standards while coordinating with internal and external stakeholders.

Graduate or higher in a scientific or health care field is required; strong communication and time management are essential.

Qualifications

• 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

• Implement and manage QA processes across organization.
• Ensure compliance with regulatory requirements.
• Collaborate with stakeholders to meet agreements and guidelines.
• Oversee quality, compliance and documentation on assigned projects.
• Identify training and development requirements for functions.
• Support audits and inspections and respond during reviews.
• Author and review SOPs and other department documents.

Skills

Quality Assurance

Team Management

Regulatory Knowledge

Independent Work

Communication

Education

Graduate / Postgraduate in scientific or health care discipline

Job description

• 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.
• 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.
• 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