Company Description Amar Biosystems is a start-up focused on developing microfluidics and microreactor-based technologies for the biopharmaceutical and life science industry. The company is dedicated to accelerating drug development, improving diagnostics, and advancing biochemical analysis to support the next generation of nanomedicines for infectious diseases, cancer, and rare diseases. Its core work includes innovative microfluidic systems for mRNA vaccines and therapeutics, emphasizing scalable and cost-effective solutions.

Amar Biosystems collaborates closely with research institutions and industry partners to translate formulations, processes, and analytics from bench to bedside. Team members join a science-driven workplace that values innovation, collaboration, and impact on patient outcomes.

Role Description The Senior Quality Assurance Specialist is a full-time, on-site role based in Mumbai. This position is responsible for overseeing quality systems and processes across microfluidics and nanomedicine development activities, ensuring compliance with internal standards and applicable regulations. Day-to-day responsibilities include developing and maintaining quality policies and procedures, reviewing batch records and documentation, and coordinating internal and external quality audits.

The specialist will monitor adherence to Good Manufacturing Practice (GMP), lead investigations into non-conformances, manage corrective and preventive actions (CAPA), and support risk assessments. The role also involves collaborating with cross-functional teams,



training staff on quality requirements, and contributing to continuous improvement initiatives to strengthen overall quality management.

Qualifications

- Candidates should possess strong skills in Quality Assurance and Quality Control to design, implement, and monitor quality systems and processes.
- Candidates should possess experience in Quality Management, including developing SOPs, managing documentation, and supporting continuous improvement activities.
- Candidates should possess in-depth knowledge of Good Manufacturing Practice (GMP) guidelines, particularly as applied to biopharmaceutical and related laboratory environments.
- Candidates should possess skills in Quality Auditing, including planning and conducting internal and supplier audits and following up on audit findings.
- Relevant qualifications include a bachelor’s or master’s degree in pharmacy, biotechnology, life sciences, chemical engineering, or a related discipline.
- Beneficial experience includes working in biopharmaceutical, nanomedicine, or microfluidics-based product development, and familiarity with regulatory frameworks (e.g., FDA, EMA, ICH).
- Additional skills that are advantageous include strong analytical and problem-solving abilities, attention to detail, effective written and verbal communication, and demonstrated capability to work collaboratively in cross-functional teams.
- Experience with CAPA management, risk assessment tools, validation activities, and electronic quality management systems (eQMS) is highly beneficial.

📌 Senior Quality Assurance Specialist (Mumbai)
🏢 Amar Biosystems
📍 Mumbai