Job Summary

The incumbent will play a key role in ensuring product quality, regulatory compliance, and operational excellence by driving Quality Management System (QMS) and In-Process Quality Assurance (IPQA) activities across manufacturing operations. This role offers an opportunity to contribute to a highly regulated IVD/Medical Devices environment, supporting continuous improvement initiatives while ensuring adherence to GMP, ISO 9001, ISO 13485, and quality standards.

Responsibilities

- Execute IPQA activities across fabrication, dispensing, manufacturing, packaging, and dispatch operations to ensure consistent product quality and compliance.
- Review and maintain SOPs, batch records, calibration schedules, logbooks, and technical documentation.
- Drive quality improvements by identifying deviations, non-conformances, and process risks, while ensuring timely investigations and CAPA implementation.
- Support QMS activities including handling of market complaints, Change Controls, audits (internal external), training initiatives, and compliance programs.
- Ensure adherence to GMP, GDP, ISO standards, safety requirements, and records management practices.




- Collaborate effectively with cross-functional teams to strengthen quality culture and operational excellence.
- Contribute to the delivery of safe, compliant, and high-quality products through a proactive, detail-oriented, and continuous improvement mindset.

Requirements

- Graduate/Post-Graduate in Life Sciences, Biotechnology, Microbiology, Chemistry, Pharmacy, or a related discipline.
- 2 to 5 years of Quality Assurance experience, including at least 1 year in the IVD or Medical Devices industry.
- Sound knowledge of GMP, Positive Documentation Practices (GDP), Change Controls, CAPA, Deviations, Non-Conformance Management, and Validation practices.
- Knowledge of ISO 9001, ISO 13485, regulatory requirements, and audit processes.
- Understanding of ELISA, Clinical Chemistry, Rapid Diagnostics, Hematology, and related manufacturing processes.
- Proficiency in MS Office and quality documentation management.
- Strong communication, problem-solving, time management, and stakeholder management skills.

📌 Officer Quality Assurance (Dehradun)
🏢 Avantor
📍 Dehradun