16 Sep
|
VWR International
|
India
16 Sep
VWR International
India
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 operationsThis role offers an prospect 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.
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, 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.
Solid communication, problem-solving, time management, and stakeholder management skills.
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 protected, compliant, and high-quality products through a proactive, detail-oriented, and continuous improvement mindset.
Disclaimer This job posting has been aggregated from external sourceRole details, content, and availability are subject to changeApplicants are advised to confirm the latest information directly on the company website before applying.
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