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
- 6+ years of QA experience in pharmaceutical, biotechnology, or life sciences.
- Solid 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.

📌 Quality Assurance Team Lead (Agra)
🏢 Soterius
📍 Agra