Astam Diagnostics is hiring for recent graduated freshers B.E./B.Tech/M.Sc. in Life Sciences, Biotechnology, Microbiology, Biomedical, or related field
Role Summary
The QA/QC Executive is responsible for supporting routine quality control activities in the IVD and Medical Devices manufacturing environment. The role involves performing laboratory testing, documentation, and ensuring compliance with applicable standards such as ISO 13485 and CDSCO Medical Device Rules..
Key Responsibilities1. Routine QC Testing
- Perform testing of raw materials, in-process samples, and finished products as per approved specifications and SOPs.
- Execute basic analytical techniques such as:
- ELISA
- PCR/qPCR (basic handling)
- Spectrophotometry
- Microbiological testing
- Record observations accurately in lab notebooks, worksheets, or LIMS.
2. Laboratory Operations
- Support daily operations of QC laboratories (microbiology, chemistry, immunology).
- Ensure cleanliness, safety, and compliance with lab practices.
- Assist in calibration and routine maintenance of instruments.
- Follow proper sample handling, labeling, and storage procedures.
3. Documentation & Compliance
- Maintain accurate and complete QC documentation as per QMS requirements.
- Follow SOPs, test methods, and work instructions strictly.
- Assist in documentation for ISO 13485 and regulatory compliance.
- Support audits by providing required records and data.
4. Quality Systems Support
- Report deviations, out-of-specification (OOS), or abnormal results to seniors.
- Assist in basic investigations and data collection for root cause analysis.
- Participate in CAPA implementation as assigned.
5. Stability & Sample Management
- Support stability studies (sample testing, data recording).
- Maintain sample inventory, retention samples, and reference standards.
6. Equipment & Method Support
- Assist in method validation and verification activities.
- Support IQ/OQ/PQ documentation under supervision.
- Ensure instruments are used as per qualification status.
7. Cross-Functional Support
- Coordinate with production for sample collection and testing timelines.
- Support R&D during trials and product development activities.
- Work with QA for documentation and compliance-related activities.
Qualifications & ExperienceEssential
- B.E./B.Tech or M.Sc. in relevant field (Life Sciences, Microbiology, Biotechnology, Biomedical).
- 0–3 years of experience in QC/QA (IVD or medical device industry preferred).
- Basic knowledge of laboratory techniques and equipment.
- Understanding of GMP/GLP and quality systems.
Preferred
- Internship or training in QC laboratory (IVD/Pharma/Medical Devices).
- Basic knowledge of ISO 13485 and CDSCO guidelines.
- Exposure to LIMS or ERP systems.
Interested candidates can reach at [email protected] or call on 9810308597.
Pay: ₹10,000.00 - ₹15,000.00 per month
Benefits:
Work Location: In person
