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9.0 - 14.0 years
8 - 18 Lacs
mumbai suburban, navi mumbai, mumbai (all areas)
Work from Office
- Provide remote QMS support for global sites, handling OOS, OOT, deviations, incidents and change controls. - Review documentation for compliance & drive continuous improvement. - Ensure timely investigation, analysis & change control initiation. Required Candidate profile - 9+ years of QC/QA experience in regulated pharma co. - Reviewing OOS, OOT, APQR & lab incident investigations, change controls & managing deviations - Strong knowledge of USFDA, EU & Health Canada
Posted 1 month ago
12.0 - 20.0 years
15 - 30 Lacs
mumbai suburban, navi mumbai, mumbai (all areas)
Work from Office
- Develop & Execute regulatory strategies - Stay updated on evolving global regulatory requirements & ensure products comply with international standards - Collaboration with Cross functional teams including R&D, QA, Clinical developments. Required Candidate profile - Strong leadership & management skills, including experience leading cross functional teams - Proven track record of successful regulatory submissions & approvals
Posted 1 month ago
2.0 - 5.0 years
3 - 8 Lacs
mumbai suburban, navi mumbai, mumbai (all areas)
Work from Office
- Identify tender opportunities aligned with company's objectives. - Prepare comprehensive & compelling tender bids and proposals; manage end-to-end tender submission process, meeting deadlines. - Ensure compliance with all relevant regulations. Required Candidate profile - 2+ years of proven experience in tender management within the healthcare or aid sector. - Strong understanding of the tender process, regulations, and compliance standards.
Posted 2 months ago
2.0 - 7.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory)....
Posted 6 months ago
2 - 7 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database • Responsible & Accountable for the assigned study conduct activities, in clinical trials • Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. • Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. • To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Labo...
Posted 7 months ago
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