BioSystems Diagnostics Private Limited (BDPL) has been distributing high-quality in-vitro diagnostic (IVD) products across India since 2003 through a strong and committed network of distributor partners.Established in 2003, BDPL began its journey with trading of IVD reagents and instruments and has since expanded into in-house manufacturing operations in India.
Job Summary:
Responsible for manufacturing, formulation, and packaging of diagnostic/medical reagents while ensuring compliance with quality standards such as GMP, ISO, and regulatory guidelines.
Key Responsibilities:
- Key Responsibilities:
Perform Incoming Inspection of RM, PM and Quality Control testing of IVD products.
Maintain QC documentation, records, and test reports and Ensure compliance with ISO 13485,
GLP and regulatory requirements.
Investigate product complaints, non-conformities and support CAPA activities.
Coordinate with Production and QA teams
Requirements
Knowledge of IVD products, diagnostic assays, and laboratory techniques
Familiarity with quality management systems and documentation practices
Solid analytical, problem-solving, and communication skills