10 Sep
|
Avantor
|
Dehradun
The Opportunity:
.
The Chance:
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.
What We Are Looking For:
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, Good 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.
How You Will Thrive & Create an Impact:
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-fun
📌 Officer Quality Assurance (Dehradun)
🏢 Avantor
📍 Dehradun