Wipro Openings in Switzerland - openings Subject Matter Expert - Validation, Subject Matter Expert – Regulatory & Safety (Clinical Development)

Job Title: Subject Matter Expert - Validation
Job Location: Basel/Switzerland

Job Title:
Subject Matter Expert - Validation

Job location: Basel/Switzerland

Job Type (Permanent/Contracting): Permanent position

    We are currently looking for professionals fulfilling the following criteria:
  • Computer System Validation & Part 11 Compliance (V&V)
  • Knowledge on software implementations and validations (Installation, Operational and Performance Qualifications)
  • Knowledge on GMP, GaMP , USFDA etc., practices
  • Expertise in Regulatory Standards of ICH, USFDA, EMEA, ISPE, PIC/S, TGA
  • Worked in eCTD (Docubridge), SPL-PLR, SAP, Orcale Clinical applications
  • Expertise in Process Validation and Qualification


Please send your resume to heike.krueger@wipro.com , mentioning "SME - Validation - Facebook" in the subject line in case your profile matches the criteria mentioned.


Job Title: Subject Matter Expert – Regulatory & Safety (Clinical Development)
Job Location: Basel/Switzerland

Job Title:
Subject Matter Expert – Regulatory & Safety (Clinical Development)

Job location: Basel/Switzerland

Job Type (Permanent/Contracting): Permanent position

    We are currently looking for professionals fulfilling the following criteria:
  • Strong industry awareness (Life Science) and proven Client Relationship Management and Business Development Skills and excellent interpersonal and communication skills
  • Knowledge of principles of Clinical development and Drug safety / PV, GxP guidelines including ICH-GCP guidelines, comprehensive understanding of regulatory compliance and FDA/EMEA regulation, guidelines, directives and any relevant regulatory requirements
  • Experience in adverse event processing; safety data analysis and reconciliation; database management, aggregate safety reports ,compliance metrics development and signal detection activities thus complying with the standards and expectations of global regulators
  • Exposure to Global Regulatory Standards of ICH, USFDA, EMEA, ISPE, PIC/S, TGA
  • Worked in Clinical and safety applications
  • Expertise in Process Validation and Qualification
  • Knowledge in Computer System Validation & Part 11 Compliance (V&V)
  • Worked in Pharma / CRO industry managing clinical / safety areas
  • Strong consulting experience
  • Exposed to working with outsourcing organizations
  • Managed EDC ,TMS, SAS from CDM perspective and case processing from drug safety
  • Experienced in Clinical integrations, validations, LSH, CDA
  • Proven expertise with CDISC standards and conversions


Please send your resume to heike.krueger@wipro.com , mentioning "SME – Regulatory & Saftety - Facebook" in the subject line in case your profile matches the criteria mentioned.












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