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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
265423BRSr. Manager - DI & Sysem ComplianceJob DescriptionYour responsibilities include , but are not limited to: 1.Ensuring that all lab instrument / equipment software is compliant with MHRA and 21 CFR Part 11 data integrity requirements (following the Novartis IT requirements). 2.Providing subject matter expertise on Data Integrity (DI) for business processes 3.SPOC for Site DI network within GxP functional areas e.g. Manufacturing , MS&T , Engineering , etc. 4.Reporting of DI related KPI s , performing DI trainings and lead the communication of DI related topics. 5.Active member of Audit teams and address the audit observations raised during self - inspection and other audits. 6.Champion the Data Integrity aspect at the SDC India site Systems Compliance 7.Support project teams and system owners on qualification procedures for timely execution of qualifications and creation / review of documents for validation and qualification (following the No - vartis IT requirements and addressing non - compliant issues). 8.Support installation of software together with Dev IT and vendor and creation and maintenance of system data lifecycle documents. 9.Single point of contact between SDC India and local and global IT and other business partners , and part of a global business support team for the global Why consider Novartis Group of Companies 817 million. That s how many lives our products touched in 2018. And while we re proud of that fact , in this world of digital and technological transformation , we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious , courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks , and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis group of companies. Join us and help reimagine medicineMinimum requirementsWhat you ll bring to the role:Masters Degree in Science or Pharmacy or MBA Successfully completed Bachelor Degree of information management , IT or business administration or an equivalent education Excellent understanding of generic pharmaceutical development organization and processesMin. 10 years of experience in relevant areaExperience in IT project management and change management IT application management / system management. Knowledge of 21 CFR Part 11 and MHRA data integrity requirements is critical Knowledgeable about Good Laboratory practice (GLP s) , Data Integrity and relevant industry standards to ensure activities are in compliance at all times Active command in English with excellent written and spoken communication skillsDivisionSANDOZ Business UnitProduct Dev SZ CountryIndia Work LocationHyderabad , AP Company / Legal EntityNov Hltcr Shared Services IndFunctional AreaInformation Technology Job TypeFull TimeEmployment TypeRegular,
Keyskills :
hange management data integrity project management it application management continuous improvement facilitation project teams music making shared services it project management