Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Validation Consultant
Eingestellt von Juice Resource Solutions Limited
Gesuchte Skills: Engineering, Consultant
Projektbeschreibung
Validation Consultant
Location: Antwerp Area
Rate: £45 - £55 p/h
Duration: 3 months Initially
OVERVIEW:
To provide support for the validation activities associated with OSISoft PI ensuring that all compliance issues and requirements of our Clients Validation Policies and Procedures are addressed.
KEY ACCOUNTABILITIES: (OSISoft test/validation support)
- Execute test sets in HP/QC related to the validation of OSISoft PI system
- Complete SDLC 6.0 assets used to validate the OSISoft PI system and residing in the Docspace system
- Suggest and sometimes may implement innovation and continuous improvement within the Validation process
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Facilitates successful team behaviour within Quality Systems and across functional areas
- Manages relationships externally and internally.
- Fosters harmony within Quality Systems.
- Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
- Ensure that all validation activities are carried out and reported in a timely manner.
- Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
- Lead by example, inculcating the Credo values in all actions within the workplace
TECHNICAL PROFILE REQUIREMENTS:
- Knowledge of GAMP5 based validation.
- HP QC/Docspace
- Basic knowledge of OSISoft PI software
DESIRABLE:
- Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Working experience of validation computer systems for use in a FDA regulated environment.
NON-TECHNICAL PROFILE REQUIREMENTS:
- Individual must also be an active team member in Validation activities
- Good Document Practices.Strong analytical and problem-solving skills
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Structured/Organized
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow and execute test (management) procedures and internal guidelines
Methodology/Certification requirements
- Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred
- English spoken and written
- Dutch is a plus
Location: Antwerp Area
Rate: £45 - £55 p/h
Duration: 3 months Initially
OVERVIEW:
To provide support for the validation activities associated with OSISoft PI ensuring that all compliance issues and requirements of our Clients Validation Policies and Procedures are addressed.
KEY ACCOUNTABILITIES: (OSISoft test/validation support)
- Execute test sets in HP/QC related to the validation of OSISoft PI system
- Complete SDLC 6.0 assets used to validate the OSISoft PI system and residing in the Docspace system
- Suggest and sometimes may implement innovation and continuous improvement within the Validation process
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Facilitates successful team behaviour within Quality Systems and across functional areas
- Manages relationships externally and internally.
- Fosters harmony within Quality Systems.
- Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
- Ensure that all validation activities are carried out and reported in a timely manner.
- Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
- Lead by example, inculcating the Credo values in all actions within the workplace
TECHNICAL PROFILE REQUIREMENTS:
- Knowledge of GAMP5 based validation.
- HP QC/Docspace
- Basic knowledge of OSISoft PI software
DESIRABLE:
- Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Working experience of validation computer systems for use in a FDA regulated environment.
NON-TECHNICAL PROFILE REQUIREMENTS:
- Individual must also be an active team member in Validation activities
- Good Document Practices.Strong analytical and problem-solving skills
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Structured/Organized
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow and execute test (management) procedures and internal guidelines
Methodology/Certification requirements
- Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred
- English spoken and written
- Dutch is a plus
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Organisation/Management