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QA Computer System Validation Consultant - CSV
Eingestellt von Elevate Direct
Gesuchte Skills: Consultant, Engineering
Projektbeschreibung
QA COMPUTER SYSTEM VALIDATION CONSULTANT/BEERSE, BELGIUM/3 MONTHS CONTRACT/35 TO 57 EUR (PER HOUR)
To assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for computerized systems.
GENERAL ACTIVITIES:
-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, J&J and Janssen policies and standards.
- Be part of 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. Be a member of cross-functional teams to realize cross-departmental objectives
- Address and follow-up of deviations occurred during execution of qualification/validation activities.
- Evaluate the incidents related to CS and propose corrective actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case.
- Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,), MAP, etc.
KNOWLEDGE:
-Knowledge of cGMP's: 21CFR11, 21CFR210, 21CFR211, Eudralex Volume 4 and annex 11, MHRA GFI on Data Integrity 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.
- Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
- Ability to multi-task and work on a variety of projects at one time.
- Ability to work independently and work in cross-functional team environment.
- Good communication skills.
- Good project management skills.
- Good problem solving skills.
THE COMPANY
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
IF YOU MATCH THESE REQUIREMENTS, PLEASE APPLY IN THE NORMAL WAY. ELEVATE WILL SEND YOU AN EMAIL, PLEASE OPEN, AND ACTION THAT EMAIL AND YOUR APPLICATION WILL BE VISIBLE TO THE HIRING ORGANISATION DIRECTLY.
To assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for computerized systems.
GENERAL ACTIVITIES:
-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, J&J and Janssen policies and standards.
- Be part of 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. Be a member of cross-functional teams to realize cross-departmental objectives
- Address and follow-up of deviations occurred during execution of qualification/validation activities.
- Evaluate the incidents related to CS and propose corrective actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case.
- Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,), MAP, etc.
KNOWLEDGE:
-Knowledge of cGMP's: 21CFR11, 21CFR210, 21CFR211, Eudralex Volume 4 and annex 11, MHRA GFI on Data Integrity 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.
- Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
- Ability to multi-task and work on a variety of projects at one time.
- Ability to work independently and work in cross-functional team environment.
- Good communication skills.
- Good project management skills.
- Good problem solving skills.
THE COMPANY
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
IF YOU MATCH THESE REQUIREMENTS, PLEASE APPLY IN THE NORMAL WAY. ELEVATE WILL SEND YOU AN EMAIL, PLEASE OPEN, AND ACTION THAT EMAIL AND YOUR APPLICATION WILL BE VISIBLE TO THE HIRING ORGANISATION DIRECTLY.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Organisation/Management