Kishan Vyas

Highly analytical Quality Assurance & Regulatory professional holding a Master of Science in Regulatory Affairs and a Bachelor of Pharmacy. Brings over two years of practical manufacturing and laboratory experience operating within strict cGMP, GLP, and GDP environments. Expert in reviewing master formulations, executed batch records, and external raw material documentation to support the commercialization of consumer-packaged goods and OTC products.

Proven ability to drive continuous improvement by investigating Out-of-Specification (OOS) results, executing corrective actions (CAPA), and maintaining Quality Management Systems (QMS). Passionate about applying a rigorous focus on scientific integrity and regulatory compliance to support private label health, beauty, and personal care manufacturing operations.

Quality & Regulatory Operations Consultant at Nytia Labs (Nytia Health) (2026-01 – 2026-06)

• Engineered simulated Quality Management System (QMS) improvement initiatives for novel health and wellness products, optimizing document control activities including the archival of SOPs and batch release policies.
• Conducted robust quality data trending on simulated formulation deviations and consumer complaints, successfully identifying recurring manufacturing issues to reduce compliance gaps by 20%.
• Spearheaded internal audit preparations and mock regulatory submissions, streamlining document collation to ensure absolute readiness for Health Canada and FDA evaluations.

Quality Assurance & Compliance Associate at Intas Pharmaceuticals (2024-01 – 2025-01)

• Reviewed over 200 master and executed batch records, SOPs, Certificates of Analysis (COAs), and analytical data to ensure absolute alignment with cGMP and GDP manufacturing standards.
• Participated actively in cross-functional investigations, meticulously tracking deviations, CAPAs, and change controls to guarantee timely follow-up and operational closure.
• Performed daily line clearance and in-process control testing across fast-paced manufacturing floors, maintaining zero critical contamination events over a 12-month production period.
• Evaluated external vendors' raw material documentation and GMP certificates to secure supply chain compliance and safeguard the integrity of incoming active ingredients and packaging components.

Quality Control & Regulatory Intern at Mediwin Pharmaceuticals (2023-01 – 2024-01)

• Supported standard analytical lab practices by preparing R&D samples and conducting rigorous technical reviews of product formulations to ensure strict dosage accuracy and ingredient compatibility.
• Assisted in facility training coordination by maintaining meticulous training records and tracking compliance metrics within the corporate learning management system (LMS).
• Leveraged strong analytical skills to perform daily calibration checks and documented performance verifications on sensitive laboratory equipment, maintaining a continuous state of audit readiness.

Master of Science in Regulatory Affairs – Northeastern University (2025-01 – 2026-05)

Bachelor of Pharmacy in Pharmacy – Gujarat Technological University (2019-08 – 2023-05)