If you are an experienced Quality Assurance professional looking to build your career in the clinical research industry, Novotech has announced an excellent opportunity for the position of Quality Assurance Auditor II in India. Candidates with relevant experience in GCP, auditing, and clinical research can apply online for this full-time position.
This role offers the opportunity to work with one of the world’s leading Contract Research Organizations (CROs), supporting global clinical trials while contributing to quality systems, compliance, and regulatory excellence.
Job Overview
Company: Novotech
Position: Quality Assurance Auditor II
Job Type: Full-Time
Location: Bangalore, Karnataka, India
Industry: Clinical Research / CRO / Pharmaceutical
Experience Required: Minimum 2 years
Qualification: Tertiary qualification in Health Science or a related field
Application Mode: Online
About Novotech
Novotech is a global full-service Clinical Contract Research Organization (CRO) established in 1997. With more than 30 offices across Asia-Pacific, Europe, and the United States, the company supports biotechnology and pharmaceutical organizations in bringing innovative therapies to patients worldwide.
Novotech is recognized as an Employer of Choice and provides employees with opportunities for professional development, flexible work arrangements, and an inclusive workplace culture.
Key Roles & Responsibilities
The selected candidate will be responsible for:
- Support the Quality Assurance leadership in QA activities across the organization.
- Assist in planning and hosting client audits and regulatory inspections.
- Perform internal and external audits of investigator sites, vendors, data management systems, protocols, clinical study reports, pharmacovigilance activities, and internal processes.
- Record audit findings and ensure timely reporting.
- Monitor implementation of corrective and preventive actions (CAPA).
- Participate in investigations of quality events and follow-up activities.
- Evaluate and manage third-party clinical trial service vendors.
- Review and approve computerized system validation documentation.
- Provide GCP and QA guidance and training to internal teams.
- Develop and review Quality Management System (QMS) procedures and documentation.
- Prepare quality metrics, status reports, and trend analyses.
- Represent the QA department during client meetings and calls.
- Maintain knowledge of national and international Good Clinical Practice (GCP) regulations and guidelines.
Required Qualifications
Applicants should possess:
- Tertiary qualification in Health Science or a related discipline.
- Minimum 2 years of experience in the research, pharmaceutical, or CRO industry.
- Previous experience in GCP monitoring and auditing.
- Strong understanding and practical application of Good Clinical Practice (GCP).
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently while managing multiple priorities.
Preferred Skills
- Clinical quality assurance expertise
- Regulatory compliance knowledge
- Internal and external auditing
- Vendor management
- Documentation review
- Problem-solving and analytical abilities
- Report writing and presentation skills
- Team collaboration and stakeholder communication
Salary
Based on industry standards for similar Quality Assurance Auditor positions in India, the expected salary range is approximately ₹12,00,000 – ₹18,00,000 per annum, depending on qualifications, experience, and company policies.
Employee Benefits
Novotech offers a competitive employee benefits package, including:
- Flexible working options
- Paid parental leave
- Flexible leave entitlements
- Wellness programs
- Professional development opportunities
- Inclusive workplace culture
- Mentorship and career growth programs
- Collaborative international work environment
Why Join Novotech?
Joining Novotech provides an opportunity to work on global clinical research projects while collaborating with experienced professionals across multiple countries. Employees benefit from continuous learning opportunities, supportive leadership, flexible work policies, and exposure to cutting-edge life sciences research.