Sudha Shukla

• 1. Equipment Qualification
• 2. Documentation and document control for QMS compliance of ISO 13485
• 3. CE IVD compliance as per MDR 2017:746
• 4. NABL experience on ISO 15189 and ISO 17025
• 5. Lab monitoring
• 6. Site monitoring

1. QMS compliance of ISO 9001:2015, ISO13485:2016 for IVD Products and ISO 17025:2017 for sequencing services for NABL compliance. Maintain trackers, filing systems, and submission logs to ensure the mentioned compliances.

2. ISO 15189 trained and lab maintenance.

3. IVDD and IVDR documentation and registration of the same in EU countries along with ISO 15223, ISO 13485, ISO 14971, ISO 9001 compliance.

4. CDSCO licensing and documentation using Sugam portal, preparation and compilation of DMF for Manufacturing Licenses – Fresh, Endorsements, Renewals

5. Registration of IVD products for Vietnam, Saudi Arabia. Coordination and followup responses to address regulatory queries and information requests.

6. Documentation and registration for ANVISA of IVD products

7. Facing External audits of Quality Austria, TUV SUD, SFDA and CDSCO audits. Supporting the site audit preparation.

8. Planning and Conducting Management review meeting Awareness of CLSI and ICH guidelines for Stability studies Working on FSSAI and ISO 18583

9. Monitoring and maintenance of lab as per ISO 14644

10. Worked on SAP transactions and Flink ISO

11. WHO-GMP compliance

12. Documentation for OOS, NIDR, Change control, CAPA and Root cause Investigation

13. Lead Internal Auditor

14. supervision of calibration/ validation of instruments, HVAC

15. Monitoring production activities and sites

16. Assistance in CE marking documentation for Instruments as well.

17. Handling NOC certificates

1. ISO 13485 compliance with respect to QMS compliance, lab monitoring and maintenance

2. CE IVD registration for IVD kits

3. Training personnel with respect to geneal QMS

4. Conducting and performing Internal audit and non-compliance closure

• 1. Delivered lectures on Quality attributes as ICH guidelines,QA-QC, Regulatory compliance, Schedule Y,M,H,T and Instrumentation of Analytical Instruments
• 2. Conducting practical’s and demonstration for SD-PAGE, Chromatography techniques, Infrared spectroscopy, Microbiology, Physical and Chemical evaluation for plant morphology
• 3. Knowledge sharing on Patent Claim drafting, understanding research papers and Self-development through presentation skills
• 4. Problem solving & troubleshooting.
• 5. Critical thinking

• 1. Analytical and stability testing of the cosmeceutical products as per ICH guidelines
• 2. Technical Documentation of regular analysis
• 3. Method transfer
• 4. Market trend analysis
• 5. Customer feedback and survey
• 6. Understandings about Audit

• 3 months Internship Daily calibration, microbiological analysis followed by analysis on IR and AAS