First Time Us Pharmaceuticals India

1. Compilation of Post Approval requirements i.e. Annual Reports, CBE-0, CBE-30, PAS, 15-Day Alert Report, PADER etc., ensuring that quality standards are met and submissions meet strict deadlines. Provident fund Office cab/shuttle Health insurance Annual bonus

M pharma if they have 5 years of experience or more or Ph.D. and less than 3-5 years of experience in nanoparticles, specifically lipid nanoparticles, nano emulsion,Pharma R&D Office cab/shuttle Health insurance Provident fund Annual bonus

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund

JD Collaborate with cross-functional teams on equipment qualifications and IQS. Ensure IT compliance through validation processes. Develop computer system validation plans and protocols. QMS candidate shud b frm pharma industry gud communic skills. Cafeteria Office cab/shuttle Accessible workspace Health insurance Provident fund Annual bonus

Job * Engineering & Maintenance Management pharma machine installation,qualifiaction as per cGMP * Ensure compliance with regulatory standards during production, * Oversee CAD drawing creation using AutoCAD software .c ompliance & Validation Office cab/shuttle Maternity benefits in mediclaim policy Health insurance Employee state insurance Maternity policy Military leave policy Annual bonus

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration and device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Health insurance Annual bonus Office cab/shuttle Provident fund

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration Medical device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Office cab/shuttle Annual bonus Health insurance Provident fund