GxP, GLP, Regulatory Environments Support Analyst
3 days ago
We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards.
Key Responsibilities:
Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation.
Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP).
Coordinate application deployments, upgrades, validations, and decommissioning.
Collaborate with stakeholders to optimize business processes and system functionality.
Maintain and review system SOPs, user manuals, and ensure audit readiness.
Liaise with IT and vendors to resolve technical escalations and system configurations.
Must-Have Qualifications:
2-3 years of relevant support or application administration experience
Strong skills in MS Excel, MS Word, and business/technical applications
Understanding of GxP, GLP, regulatory environments, and computer validation principles
Bachelor's degree (or equivalent experience)
Preferred Skills:
Familiarity with NG/Pristima, Tox Reporting tools
Experience supporting lab-based systems or instruments
Knowledge in small project management and release control
SupportAnalyst #ApplicationAdmin #ITSupport #HiringNow #GLPCompliance #ApplicationSupport #HealthcareIT #RemoteJobs #ContractJobs #SOP #SystemValidation #ITJobsIndia #ResumeCall #SuzvaHiring-
GxP Manual Functional Tester
6 days ago
Pune, Maharashtra, India Quantum Integrators Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition - GxP Manual Functional TesterLocation - Pune/NagpurDuration - Full timeOffice Hours: India/UK TimeMinimum 5+ years of experience in manual testing in GxP-compliant environmentsGood understanding of STLC, Functional testing, FIT, UAT, Defect ManagementHands on experience in FIT Test case design and executionsHands on experience in UAT test...
-
CSV & Regulatory Compliance Specialist
6 days ago
Pune, Maharashtra, India TransPerfect Full time ₹ 20,00,000 - ₹ 25,00,000 per yearAbout the Role:We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems...
-
Regulatory Operations Analyst
2 weeks ago
Pune, Maharashtra, India Deutsche Bank Full time ₹ 6,00,000 - ₹ 18,00,000 per yearAbout The Role : Job TitleRegulatory Operations Analyst LocationPune, India Role Description As part of the COO function, the Global Reporting & Performance Measurement department is responsible for the provision of client-specific and regulatory reports for the entire DWS Active, Passive & Alternatives business area.- As Operation Analyst in the...
-
Pune, Maharashtra, India TransPerfect Full time ₹ 15,00,000 - ₹ 25,00,000 per yearAbout the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems...
-
Assistant Manager – Regulatory
1 week ago
Pune, Maharashtra, India Auxilife Scientific Services Pvt. Ltd. (a unit of GPC) Full time ₹ 8,00,000 - ₹ 24,00,000 per yearLocation: Pune, Maharashtra Reports To: General ManagerCompany Overview: Auxilife is a leading agrochemical research and regulatory solutions provider, focused on developing innovative crop protection products while ensuring compliance with regulatory requirements globally.Position Summary: The Assistant Manager – Regulatory & Toxicology will support...
-
Regulatory Affairs Manager
22 hours ago
Pune, Maharashtra, India Batavia Pharma Pvt Ltd Full timeRole & responsibilitiesRole Overview:The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory...
-
Business Data Analyst
3 days ago
Pune, Maharashtra, India Systems Plus Full time ₹ 6,00,000 - ₹ 18,00,000 per yearLocation: PuneEmployment Type: full-timeDesignation: Business Data AnalystJob DetailsJob Title: R&D IT Business Data AnalystPosition Summary:We are seeking a highly motivated and detail-oriented R&D IT Business Data Analyst to serve as a critical liaison between IT, R&D, and cross-functional teams in the Biotech Industry. This role supports the integration...
-
Regulatory Reporting Analyst
3 days ago
Pune, Maharashtra, India Apex Group Ltd Full time ₹ 5,00,000 - ₹ 8,00,000 per yearThe Apex Group was established in Bermuda in 2003 and is now one of the world's largest fund administration and middle office solutions providers.Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully...
-
Regulatory Analyst
1 week ago
Pune, Maharashtra, India Cyient Full time ₹ 15,00,000 - ₹ 25,00,000 per yearDevelop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745).Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers.Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing...
-
Assistant Manager Regulatory and Toxicology
2 weeks ago
Pune, Maharashtra, India Auxilife scientific services pvt ltd Full time ₹ 15,00,000 - ₹ 25,00,000 per year1. Regulatory Affairs: -o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products.o Liaise with client and regulatory authorities for approvals, clarifications, and queries.o Maintain up-to-date knowledge of regulatory requirements in India and...