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.