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/SwitzerlandJob 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/SwitzerlandJob 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.
