Lalit Singh

Throughout my career, I have attempted to explore different avenues in the life sciences and medical sciences to upgrade my knowledge, skill sets, and pursuit of realizing high-quality products. I am a staunch believer in transforming knowledge to achieve excellence in the healthcare sector through the promotion of sustainable businesses.

Catering globally for providing quality in-vitro diagnostics/ medical device products by complying with applicable regulatory and QMS requirements, including WHO-prequalifications, CDSCO, ANVISA, and EU-regulations. The strategic decision-making process, process improvement (verification and validation), stakeholder engagement, and tailored submission of Dossiers to specific markets are some of the significant contributions. Experience in Regulatory affairs and QMS is helpful in ensuring the fruition of desired results within the stipulated time. Further, a thorough understanding of applicable regulatory standards and QMS helps in the timely guidance, submission of dossiers, and market approvals. #PMP #Six-Sigma Black Belt #OpeX #STQ certified professional.

Leading IVDD to IVDR transitioning of blood grouping (class D) products
-Super-admin in QMS software
-Effectiveness of QMS
-ADRs, FSN, and FSCA
-Pharmacovigilance- PMS, PSURs, PMPF, QRM, Benefit-Risk analysis, and Trend Reporting
-Preparation, and review of QM & Quality policy of TDPL group of companies.
-Technical documentation review & EU-conformity
-WHO-PQ, Post-approval changes, Dossier review & submission
-PMS, Change control, OOS, CAPA, Deviation, Incident, Complaint investigation, & ensuring the state of the art of the device

-Qualification (URS, DQ, FAT, SAT, IQ, OQ, PQ), verification, and validation 
-Providing QMS trainings on Sampling procedure (ISO 2859 & 3951, WHO TRS 929), Stability studies (ISO 23640), PMS (ISO 20416), Risk Management (ISO 14971), QMS (MDR, EU-IVDR 2017/746,745), -Process validation and technology transfer (WHO TRS 961), etc.
-Handling WHO-Prequalification, EU-conformity, CDSCO, IQA & Vendor audits.
-Supplier qualification, auditing, re-evaluation, rating, and performance evaluation.
- Well versed with ISO 15223, ISO 20417, ISO 18113, ISO 11133, ISO 14644, ISO guide 35/80, ISO 17025 etc.

-Well-versed with Medical devices, IVDs, Pharmaceuticals, Cosmeceuticals, Nutraceuticals and their QMS,  regulatory standards and quality operations.

B.Pharma, M.Pharma, PhD-Medicinal Plants