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Senior eCompliance QA Expert


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
13-11-2016
Job Code:
58278584
Categories:
  • Biotechnology & Science
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Job Details

Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure. Provide oversight, and guidance in the development and implementa- tion of Novartis GxP computerized Systems and processes, including on-going im- plementation of Data Integrity technical controls within IT systems landscape. Closely cooperate with functional IT staff in the compliant development and delivery of computerized systems to meet GxP requirements. Review and approve project related documents for all Global GxP relevant systems including determination of GxP applicability.1.Ensure implementation of the e-Compliance strategy and all applicable Novartis & regulatory requirements for all GxP regulated computerized systems & associated infrastructure.2.Provide oversight, and guidance in the development & implementation of Novartis GxP computerized Systems and processes, including on-going implementation of Data Integrity technical controls within IT systems landscape.3. Review & approve project related documents for all Global GxP relevant systems including determination of GxP applicability. Review and approve High Level Risk Assessments (HLRA), standards & documents for all Global GxP/non-GxP relevant systems including determination of GxP applicability. 4. Support the life-cycle of GxP computerized systems with periodic re-evaluation of the validation status, change controls, deviations management ensuring that relevant documentation is in place & maintained according to the Novartis requirements. 5 Closely cooperate with functional IT staff in the compliant development & delivery of computerized systems to meet GxP requirements. 6.Support the development, maintenance & effective implementation of appropriate standards and non-contradictory processes for governing GxP computerized systems.7.Support appropriate benchmarking with industry for trends & changing regulations to ensure that the Novartis standards & requirements are sustainably maintained and aligned and compliant with current HA requirements and expectations. Integrate into internal NVS regulatory processes accordingly.8.Support Data Integrity activities incl. awareness campaigns and associated trainings encompass e- Compliance and CSV related material. Support the de- livery of such training to cross-divisional targeted audience.9.Support the development and implementation of adequate eCompliance standards in established quality risk assessment Processes to ensure that eCompliance and technical requirements for data integrity are adequately covered. 10. Collaborate with GCA for on-going review of GCA audits related to CSV and DI observations. Ensure feedback into QM trigger process for any updates as necessary.11. Ensure that IT relevant vendors are adequately assessed according to the Novartis strategy and requirements; support the execution of vendor qualification activities, as appropriate. 12. Manage external contractors as necessary to support relevant projects and en- sure all internal training is completed as appropriate. - Also see CompetanciesMinimum requirementsDegree in Life Sciences, Pharmacy, Engineering or Information Technology; advanced degree preferred Fluency in English (oral and written), additional language(s) a plus A minimum of 6-8 years of relevant experience in the Pharmaceutical Industry and in particular in regulated functions such as Quality and/or IT. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Part11 requirements. Profound experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing and Quality space (e.g. ERP/SAP, CTMS, MES, LIMS); Experience in project management of large global IT projects preferred Track record of successful cross-divisional/cross- functional work with complex international and multidisciplinary teams. Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude. Ability to effectively interact and present to Management, as well as to external audiences
Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 6-8

Requirements

ERP/CRM | Internet/E-commerce | Project Leader/ Project Manager | Quality Assurance/Testing
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