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| Job Location | Mohali |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Ensure compliance with SOPs/Guidelines, ICH-GCP, and any otherapplicable local and international regulations, and participate ininternal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technicalstandards (e.g. CDISC, 21 CFR Part 11, and electronicsubmissions).QualificationsExcellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and internationalregulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment.,
Keyskills :
data managementregulatorywork effectivelyinternational regulationscfr21 cfrsas programmingreportingsasregulatory requirementscompliancesdtmichgcp