Validation Engineer
Postuler à cette offre
- Rattachement de poste : This mission is based in Holland
- Expérience : 2 - 5 years in validation process
- formation : Engineer or Equivalent
- Langues : Fluent in English
- Date de début : ASAP
- Descriptif de l'offre :
To support the SLDC & CSV of the following tasks including :
- Technical project planning (Hardware / Software / Licensing / logistics)
- Business analysis / data modeling
- Create MISAMM staging database in data warehouse
- Design and build entry application (iterative, based on requirements)
- Investigate XML output model and load specifications
- Determine high level solution outline
- Build functional requirement specifications
- Assist with URS development
- Set up validation plan
- Investigate data quality and database key management
Short term
- Collect the XEVMPD data set necessary for submission in July 2012.
- Develop a User Requirement Specification describing the to-be situation.
- Develop an interim system which supports the following functionalities :
- Import of in-scope data from MISAMM. (Reg Submission)
- Import / linking to data sources for regulatory standard vocabularies.
- Translation of MISAMM terms to standard vocabularies.
- Definition of master data set for data points not yet available in MISAMM. (Reg Submission)
- Data entry of data points which are not in MISAMM.
- Creation of system data (e.g. sequences) to allow the storage of the business data in a data structure in line with the XEVMPD guidelines.
- Creation of XML message to be sent to regulatory authorities including the Astellas data.
- Ability to add, edit and delete data when the system goes into maintenance mode to support the business change control processes around this data.
Long term
- Include the XEVMPD requirements for the XEVPRM data in the URS for the new RAPID (Reg Submission) system.
- Consider the storage of the SSI data which will become mandatory in due course.
- Vos qualités :
- Project Life Cycle and GMP Regulations,
- Validation experience of GAMP systems would be an advantage,
- Excellent interpersonal, communication, facilitation and team working skills
- Adaptable and flexible,