Gokulakrishnan Kumar
Quality Assurance & Regulatory Specialist GDP & cGMP Compliance Pharmaceutical Manufacturing & Distribution
- Role
- Regulatory Assistant at Smartway Pharmaceuticals
- Location
- Salem, TN, IN
- LinkedIn followers
- 500 followers
About Gokulakrishnan Kumar
Quality Assurance and Regulatory professional with 6+ years of experience across…
Experience
Regulatory Assistant
Jul 2023 — Present · London, GB
Support RP activities ensuring GDP and MHRA compliance- Manage controlled drug applications and COO documentation- Lead regulatory risk assessments for temperature-sensitive shipments- Conduct supplier/customer qualification and verification- Handle mock recalls, deviations, and CAPA in eQMS- Liaise with NCAs for high-risk shipment documentation- Investigate complaints and perform trend analyses- Communicate audit findings to RP and QA leadership
Education
PERIYAR COLLEGE OF PHARMACEUTICAL SCIENCES FOR GIRLS (Inst. Code - 031), TIRUCHIRAPALLI
Bachelor of Pharmacy - BPharm, Pharmacy, Pharmaceutical Sciences, and Administration
2014 — 2018
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