Compliance Specialist

Job Description

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11. Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation. Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Trackwise, CRM, IAM, etc.) Experience in ensuring the compliance of GxP application validation and Infrastructure Qualification Successful cross-divisional/functional work with complex international teams Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication, interpersonal skills, and critical thinking COMPANY : SANDOZ LOCATION : HYDERABAD CONTRACT FOR 6 MONTHS WILL BE RENEWED ON PERFORMNCE SHARE RESUMES TO NEDUNURI.SAIKUMAR@MANPOWER.CO.IN