Quality Assurance Specialist – QMS & Documentation

About the role

The Quality Assurance Specialist will lead the quality management system (QMS) for the Life Science division in India. You will ensure that products and processes meet regulatory standards and drive continuous improvement across the product lifecycle.

Key responsibilities

• Develop, implement and maintain the QMS in line with FDA, EMA, NABL, ANAB and ISO/GMP requirements.
• Plan, conduct and follow‑up on internal and external audits and investigations.
• Collaborate with cross‑functional teams to guarantee product quality from development through release.
• Monitor quality metrics, analyse trends and initiate corrective actions.
• Prepare, review and control quality documentation such as SOPs, validation protocols and reports.
• Provide training and guidance on quality assurance practices and regulatory compliance.
• Lead continuous‑improvement projects to enhance product quality and operational efficiency.

Required profile

• Master’s degree in Life Sciences, Chemistry, Engineering or a related field.
• 7‑9 years of experience in quality assurance within pharmaceutical, chemical, life‑science or biotechnology industries.
• Strong knowledge of regulatory requirements (FDA, EMA, NABL, ANAB) and quality standards (ISO, GMP).
• Excellent analytical, problem‑solving and communication abilities.
• Ability to work collaboratively in a fast‑paced, team‑oriented environment.

Required skills

What we offer

• A diverse, inclusive culture that values curiosity and innovation.
• Opportunities for professional growth and continuous learning.
• Contribution to impactful healthcare, life‑science and electronics solutions.