Are you passionate about quality assurance and regulatory affairs in the biotechnology sector? NeoDx Biotech Labs Pvt. Ltd., a leading ISO 13485:2016-certified molecular diagnostics company, is hiring a Junior QA/RA Executive for its Bengaluru facility. This full-time, on-site role offers an exciting opportunity to contribute to cutting-edge in-vitro diagnostics (IVD) and ensure compliance with national and international standards. If you have a life sciences background and 1-2 years of experience in quality management systems (QMS), this is your chance to grow with a dynamic team in Bengaluru, Karnataka.
Job Responsibilities
As a Junior QA/RA Executive at NeoDx Biotech Labs, you will play a critical role in maintaining quality standards and regulatory compliance. Your key responsibilities include:
- Monitoring and Approving QC Activities: Oversee production quality control (QC) activities and document them in the QMS portal (SAP).
- Raw Material Inspection: Review and approve incoming raw material inspection records in SAP.
- Final QC for Lot Release: Perform quality checks during primary packaging for kit assembly.
- QMS Implementation: Update standard operating procedures (SOPs) and processes for QMS changes.
- Handling Non-Conformities: Document out-of-specification (OOS), non-conformance (NC), and risk observations.
- Log Maintenance: Maintain logs for production infrastructure, equipment maintenance, and retainers.
- Regulatory Compliance: Identify and implement quality and regulatory requirements for labelling, QC improvements, and product registration (CDSCO, CE-IVDR, QSR 21 CFR).
- Audit Support: Assist during internal and external audits and inspections.
- Additional Tasks: Gather post-market surveillance (PMS) data, complaint data, and corrective and preventive action (CAPA) data as needed.
Qualifications and Skills
To succeed in this role, candidates should meet the following requirements:
- Educational Background: Bachelor’s or Master’s degree in Biotechnology or any Life Sciences discipline.
- Experience: 1-2 years of experience in quality assurance, regulatory affairs, or QMS in a biotech, IVD, or medical device company.
- Technical Skills:
- Proficient in SOP creation and documentation.
- Knowledge of ISO 13485:2016 and ISO 14971 standards.
- Familiarity with electronic QMS (eQMS) or G Suite-based QMS is a plus.
- Experience in manufacturing plants for IVD or medical devices is advantageous.
- Soft Skills:
- Strong written and oral communication skills.
- Excellent organizational and creative thinking abilities.
- Ability to work independently and collaboratively in a dynamic environment.
- Strong multitasking, prioritization, and time management skills.
- Capability to interpret and apply regulatory guidelines effectively.
Benefits of Joining NeoDx Biotech Labs
- Career Growth: Work in an innovative, ISO-certified molecular diagnostics company with opportunities to advance in QA/RA.
- Dynamic Work Environment: Collaborate with a skilled team in a state-of-the-art facility in Bengaluru.
- Impactful Role: Contribute to high-quality IVD products that make a difference in healthcare.
- Professional Development: Gain hands-on experience with SAP, eQMS, and international regulatory standards like CDSCO and CE-IVDR.
