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COMPUTER SYSTEM VALIDATION (CSV) CONSULTANT

Preethi

Full time |  Permanent  |  Fresher  |  Salary type not mentioned Salary not mentioned  |  1 Jobs  | English

Job Description

Within our Enterprise Risk Services department in Diegem, we are currently looking for a (m/f):

COMPUTER SYSTEM VALIDATION (CSV) CONSULTANT (FDA, PART 11)

Responsibilities:
As a Computer System Validation (CSV) consultant you will:
. Plan and coordinate computer system validation (CSV) projects (FDA, Part 11);
. Provide regulatory compliance and computer validation guidance and support ;
. Create system validation deliverables (validation plan, user requirements, risk analysis, test protocols, validation reports);
. Perform a risk analysis;
. Plan and coordinate the validation testing;
. Perform system audits for compliance with good practices and regulatory requirements;
. Assist in setting up a quality management system.

REQUIRED SKILLS:
. You obtained 5 to 8 years of experience in computer system validation (CSV);
. You have experience with validation of ERP systems;
. Good understanding of quality management systems;
. You have experience and good understanding of the regulations and industry standards such as ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK;
. Experience in working in regulated industries;
. Full professional proficiency in Dutch and English are mandatory. Knowledge of French is an asset;
. You are a good organizer and can show diplomacy and creativity. Your approach is client and result oriented and you have excellent social and communication skills.

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