Professional CSV Specialist 20%

For our pharma client in Basel we are currently looking for a

PROFESSIONAL CSV SPECIALIST 20%

TASKS & RESPONSIBILITIES:

MAIN TASKS:

- Plan, lead and report Validation Activities in small to big IT projects
- Provide coaching and consulting for IT customers in establishing a compliant system.
- Ensure that regulatory and internal specifications are adhered to additional tasks

RESPONSIBILITIES:

- Provide regulatory requirements for a computerized system in all stages of the system delivery process (Define, Design, Build, Test, Deploy)
- Participate in system risk and functional risk assessment activities and provide validation subject matter expertise for identification of risks
- Determine testing strategy, requirements and acceptance criteria
- Provide training CSV related to project teams
- Verify system installation and assure configuration controll is in place
- Participate in the test management and assessment of deviations
- Ensure transfer activities meet predefined acceptance criteria
- Confirm test results, deviations, issue resolutions and deviations from plan are documented
- confirm traceability and testcoverage
- Summarize and document all validation activities, including data migration and/or data loading, prior to release a computerized system for use
- Ensure any outstanding transition activities are executed in compliance with validation plan

MUST HAVES:

- +5 years of GxP industry experience (in similar roles)
- Sound background of CSV
- SAP experience (at least 2-3 years of experience in including a full-life cycle implementation in the role of a validation lead or IT Quality Consultant)
- Familiar with heterogeneous, multi-cultural global environment
- Fluent English (written & oral)
- Transparent, open & pro-active communication, engaging
- Open for travel)

NICE TO HAVES:
++ Fluent German speaking
++ HP ALM
+ HPSM/ServiceNow for ITSM processes (where needed)

START DATE: 01.09.2018
DURATION: UNTIL END OF YEAR WITH POSSIBLE EXTENSION
WORK LOAD: 20%
WORK LOCATION: BASEL AREA

Are you interested to work in this challenging position? Alessia Biassoli, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail to (see below)

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