Amit Garg

Background

About Amit Garg

Worked at Sr Positions of Quality functions (QA/QC) in reputed organisations like Claris Lifesciences, Capsugel India, Strides Arco lab, Radicura Pharmaceuticals, Ess Jee Pharmaceuticals specialized in sterile & Non sterile formulation tablets, soft & hard gelatin capsules, injectables. Regulatory Audits Faced: US-FDA, UK-MHRA, SA-MCC, Aust- TGA, Brazil-ANVISA, and WHO- GMP. 30 yrs of experience in Quality Operations (QC/QA) of dry powder sterile Injectables, liquid Injectables,Oral Liquids, Tablets, Capsules, dosage forms with experience of new manufacturing facility validations & qualifications of clean rooms, equipments, audits, trainings etc. Personal Attributes: Team player dedicated to quality and continuous improvement. Strong communication, technical, and interpersonal skills, and demonstrated project management capabilities. Provided leadership and mentoring to the fellow team members in their carrier development. I Can, I will Attitude. Specialties: •Review of technical dossiers for international market. •Review of dossiers, validation protocols and study reports. •Ensure the implementation of GLP/GDP in the operation of laboratory.Stability Studies, Risk Assessment,Quality Management Professionally qualified, hardworking, team leader with sound technical skills and having interests towards keeping abreast of the developments and the latest trends QA/QC & Regulatory affairs in Pharma industry. liaison with local FDA regulatory bodies.