Karthick J Email & Phone Number

Chennai, Tn, In

Chennai, Tamil Nadu, India

Chennai

• Prepared and submitted of license applications like NOC, Test license, RLD Import license, API Import license, domestic and Export manufacturing license, WHO GMP, Export NOC, COPP, FSC along with renewal activities.• Successfully managed & reviewed for the submission of Test license application with relevant supporting documents through online SLA portal.• Actively reported for submission of responses to queries received from SLA/CLA on the submitted License application by coordinating with CFT.• Getting Notarization of legal documents based on the county requirements.• Collaborated with various departments like R&D ,Project management team, Supply chain team, ROW RA, Plant RA for time to time submission of licensing documents to CDSCO/DCA.• Reviewed documents for preparation of the dossier to emerging ROW markets.

Chennai, Tamil Nadu, India

• Successfully managed & reviewed new batch records as per Master Product Specifications or Technology Transfer Documents.• Expertly Executed & Prepared the Issuance, Review, Retrieval of Batch Manufacturing and Packing Records For Solid Dosage Form, Liquid Dosage Form, Topical Dosage Form.• Supervised the Batch Release Documents to get Approval from Client for Releasing of Finished Goods.• Collaborated with the Department Heads in Internal Audit.• Actively Reported to the Quality Assurance Head about any Discrepancy or any Deviation to CGMP in day to day activities.• Assumed the role of Custodian of all the Retrieved Batch Manufacturing Records & Batch Packing Records.• Contributed to the team in meeting the Requirements of EMS, QMS and OHSAS Systems & Policy.

Chennai, Tamil Nadu, India

Tamil Nadu, India

• Developed Reformulation of various products for drug repositioning, New Drug Dosage Form.• Prepared materials for Submission to Research Scientists.• Preparation, Optimization and implementation of scale-up processes.• Collaborated with the Department Heads during Internal Audit.• Evaluation, Estimation & Preparation of batches for process remediation activities like quality investigations and CAPA Studies, Coordinated with the Research Scientists.• Analyzed Pre-formulation study.Quality Assurance :• Reviewed of BMRs, Process change proposals, Sops. • Prepared and Reviewed of Protocols, stage wise Product Development Reports, Quality overall summaries.• Maintained In-house files to ensure complete documentation.

Advanced Pg Diploma In Regulatory Affairs And Quality Assurance, Apgdra-Qa

Bachelor Of Pharmacy - Bpharm