Validation Expert (CSV, Annex11, GxP, 21CFRPart11)- German & English s

Our client, one of the biggest pharmaceutical companies based in Basel, is looking for a German speaker VALIDATION EXPERT.

This is a 1 YEAR CONTRACTING role based in Basel and planned to start in January 2018.

Are you a VALIDATION EXPERTwith strong COMPUTER SYSTEM VALIDATION (CSV) experience and currently looking for your next project?

If so, please have a look at the opportunity we can offer you:

TASKS:

GMP training according the client quality system and training concept (including all relevant SOPs for analytical systems)
Writing SOPs E-SOPs
Input change management in TQW (= electronic system for change requests)

- System administration for computerized systems

GMP
Non-GMP (DQP)

- Admin for analytical software applications

User administration
Creation of analytical templates/protocols
Data administration

- Troubleshooting, repairs, changes to analytical systems and system-specific data Servers
- Initial qualifications, migrations; including all required documents

Preparing qualification logbook, qualification plan, URS (= User requirements)
Authoring IQ13 documents, OQ/PQ for verification of ERES (=Electronic Record and Electronic Signature)

- Full system responsibility of pre-defined systems (role of the instrument responsible person)

Alignment with SO, QA and instrument users
Periodic requalification and functional checks
Keeping system binder up to date
Coordination of external service and repairs
Input for cost prediction and control

IDEAL PROFILE:

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At least 3 YEARS EXPERIENCE in COMPUTERIZED SYSTEM VALIDATION (CSV), instrument or software validation or related area within a regulated industry
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General knowledge of GXP, 21CFRPART11, ANNEX 11, or knowledge in other quality systems
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Good communication skills, very good written and spoken ENGLISH and GERMAN

Please note, we can only consider EU/CH candidates or those with a valid work permit for Switzerland.

Are you interested with this opportunity and would like to have more information? Please get in touch with Florence Wespiser ( (see below) )