Quality Assurance Team Lead

Soterius, Inc.; Dadri; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Soterius, Inc. is seeking a seasoned QA professional to implement and manage quality assurance processes across the organization, spanning operational, regulatory, and IT domains. The role includes training, audits, inspections, and ensuring alignment with internal agreements and regulatory guidelines.

You will oversee deviation management, change control, RCA, and CAPA, while coordinating with stakeholders to maintain robust documentation and compliance for all assigned projects.

Qualifications

• 6+ years of QA experience in pharmaceutical, biotechnology, or life sciences.
• Strong knowledge of GVP, CSV, GAMP, audits, and regulatory inspections.
• Experience in Deviation Management, Change Control, RCA, and CAPA.
• Experience in team management, training, mentoring, and cross-functional coordination.
• Strong communication, analytical, organizational, and time-management skills.
• Ability to work independently and manage multiple priorities.

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.
• Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidelines.
• Ensure compliance with assigned projects including operational, regulatory and IT domains; support 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 during audits and inspections as needed.
• Own assigned projects and tasks to ensure timelines and quality standards.
• Train and mentor personnel as needed.
• Author and review SOPs and other documents relevant for department.

Skills

QA experience

GVP & CSV & GAMP

Deviation Management

Change Control

RCA & CAPA

Leadership & Training

Communication & Time Management

Education

Science degree

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

• 6+ years of QA experience in pharmaceutical, biotechnology, or life sciences.
• Strong knowledge of GVP, CSV, GAMP, audits, and regulatory inspections.
• Experience in Deviation Management, Change Control, RCA, and CAPA.
• Experience in team management, training, mentoring, and cross-functional coordination.
• Strong communication, analytical, organizational, and time-management skills.
• Ability to work independently and manage multiple priorities.

Educational Requirements

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