CSV consultant

작업 내용

???? Your Next Career Move Starts Here! ????

We are thrilled to offer you an exciting opportunity to join Onesource as a "CVS Consultant". Please feel free to reach out to me directly at sagar.korukonda@onesource.one for more details or to discuss this opportunity further.

Please find below job description:

Job Title: CSV consultant

Contract Duration: 6 Months first

Location: Geel, Belgium

Work status: Hybrid (2 days Onsite remaining days are remote)

Languages: Dutch and English

JOB DESCRIPTION:

RESPONSIBILITIES

· Assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for computerized systems.

· Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis’s, Validation Plans, tests, etc…) in order to maintain compliance to regulations, guidelines

· Be part of IT/engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.

· Address and follow-up of deviations occurred during execution of CSV activities.

· Evaluate the incidents related to CS and propose corrective/preventive actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if necessary.

· Provide periodic reports on quality system compliance (metrics).

· Prepare for system audits and inspections.

· Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,), MAP, etc.

· Maintain a current knowledge of international regulations, guidelines and new evolutions related to CSV. Implement this knowledge to maintain and improve Computerized Systems Validation.

Skills:

· Knowledge of cGMP’s: 21CFR11, 21CFR210, 21CFR211, Directives 75/319/EEC and 2003/94/EC Volume 4 and annex 11 and related GMP Guidelines and Preambles.

· Knowledge of GAMP’s: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System).

· Knowledge of SW development and testing processes.

· Knowledge of Quality auditing

· Knowledge of Software quality metrics

· Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.

· Ability to multi-task and work on a variety of projects at one time.

SYSTEM KNOWLEDGE

· Process control and IT systems used within pharmaceutical and chemical manufacturing: PLCs, MES, LIMS, warehouse management systems, monitoring systems…

· Deviation and Change Management Systems (f.e`. COMET, IRIS)

· Microsoft OS, networks, virus protection

· Test Tools (f.e. qTest, Kneat)

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