First Time Us Pharmaceuticals India

12 Job openings at First Time Us Pharmaceuticals India
Regulatory Affairs Executive Navi Mumbai 3 - 5 years INR Not disclosed Work from Office Full Time

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

Research Scientist Navi Mumbai 3 - 5 years INR 60.0 - 84.0 Lacs P.A. Work from Office Full Time

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

Sr Executive Compliance QA Navi Mumbai,Mumbai (All Areas) 5 - 10 years INR 7.0 - 7.5 Lacs P.A. Work from Office Full Time

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

Senior Executive Navi Mumbai 3 - 6 years INR 36.0 - 60.0 Lacs P.A. Work from Office Full Time

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

Computer System Validation Engineer Navi Mumbai 3 - 5 years INR 84.0 - 96.0 Lacs P.A. Work from Office Full Time

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

Asst. Manager OR Manager Engineering Navi Mumbai 8 - 13 years INR 6.0 - 12.0 Lacs P.A. Work from Office Full Time

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

Regulatory Affairs Specialist Navi Mumbai 3 - 5 years INR 2.4 - 6.0 Lacs P.A. Work from Office Full Time

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

Regulatory Affairs Specialist in Medical device Navi Mumbai 3 - 5 years INR 2.4 - 6.0 Lacs P.A. Work from Office Full Time

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

Research Scientist (PHD) navi mumbai 3 - 5 years INR 6.0 - 8.4 Lacs P.A. Work from Office Full Time

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

It Manager navi mumbai 10 - 11 years INR 6.0 - 8.4 Lacs P.A. Work from Office Full Time

JD. * Lead IT strategy & operations: infrastructure, servers, Oracle ERP/NetSuite. * Ensure GMP pro custamization,compliance: systems, audits, security, cybersecurity. * Manage LIMS installation, SER, PRODUCT serialization: GMP adherence. Office cab/shuttle Health insurance Provident fund Annual bonus

Ipr Associate navi mumbai 5 - 7 years INR 6.0 - 12.0 Lacs P.A. Work from Office Full Time

Responsibilities: * Conduct patent searches & analyses * Manage trademark portfolio * Collaborate with legal team on IP matters * Ensure compliance with IP laws worldwide * Draft patents & manage intellectual property rights Office cab/shuttle Health insurance Provident fund Annual bonus

IPR Associate navi mumbai 3 - 5 years INR 6.0 - 12.0 Lacs P.A. Work from Office Full Time

Responsibilities: * Conduct patent searches, draft patents, landscape IPR portfolio. * Manage intellectual property rights, laws & litigation. * Perform prior art searches, infringement analysis & FTO checks. Ensure compliance with IP laws worldwide Provident fund Health insurance Office cab/shuttle Annual bonus