Detalhe da Oferta:
This is a remote position from Portugal.
We are looking for a skilled Validation Consultant to support the BIS eCompliance Team with activities related to Computer Systems Validation (CSV) and IT Quality Processes.
Must-have:
- Experience with management of Study Clinical Data
- Experience in SAS Life Science Analytics Framework (e.g. implementation and / or operation of SAS tools, as well as the creation of the related documentation)
Roles and responsibilities:
- Write the software validation deliverables and initiate review and approval document lifecycles in EDMS.
- Ensure the compliance with the methodology and SOP’s and ensure the use of relevant tools.
- Ensure that the project validation deliverables are complete and consistent and delivered on time.
- Ensure that project-related issues and deviations are recorded.
- Assist in writing, reviewing Validation SOPs and templates.
- Assist in resolving Computerized System Validation compliance issues.
- Create and manage quality events such as change controls, deviations, CAPAs, etc.
- Ensure timely, open, and effective communication to relevant stakeholders.
- Ensure project timelines are followed, and potential issues are communicated.
Requirements
- Experience in biopharmaceutical or development sciences, validation consulting for computer systems, understanding of global regulatory requirements, attention to detail, and ability to work autonomously.
- Preferable experience with clinical data management and SAS Life Science Analytics Framework.
- Master's degree in Bio-engineering, Chemistry, Pharmacy, or related fields.
- Proficiency in English and MS Office.
- Experience with Veeva software systems or similar (ERP, QMS) is an asset.
Benefits
- Remote work
- Food ticket
- Health insurance
- Training and access to certification vouchers
- Work-life balance initiatives
- Referral program
- Birthday off
- Give back day – enjoy a day to give back to society!
Apply here: https://zrec.eu/MOmMa?source=CareerSite or send your updated CV to with the reference ZR_51_JOB
We are looking for a skilled Validation Consultant to support the BIS eCompliance Team with activities related to Computer Systems Validation (CSV) and IT Quality Processes.
Must-have:
- Experience with management of Study Clinical Data
- Experience in SAS Life Science Analytics Framework (e.g. implementation and / or operation of SAS tools, as well as the creation of the related documentation)
Roles and responsibilities:
- Write the software validation deliverables and initiate review and approval document lifecycles in EDMS.
- Ensure the compliance with the methodology and SOP’s and ensure the use of relevant tools.
- Ensure that the project validation deliverables are complete and consistent and delivered on time.
- Ensure that project-related issues and deviations are recorded.
- Assist in writing, reviewing Validation SOPs and templates.
- Assist in resolving Computerized System Validation compliance issues.
- Create and manage quality events such as change controls, deviations, CAPAs, etc.
- Ensure timely, open, and effective communication to relevant stakeholders.
- Ensure project timelines are followed, and potential issues are communicated.
Requirements
- Experience in biopharmaceutical or development sciences, validation consulting for computer systems, understanding of global regulatory requirements, attention to detail, and ability to work autonomously.
- Preferable experience with clinical data management and SAS Life Science Analytics Framework.
- Master's degree in Bio-engineering, Chemistry, Pharmacy, or related fields.
- Proficiency in English and MS Office.
- Experience with Veeva software systems or similar (ERP, QMS) is an asset.
Benefits
- Remote work
- Food ticket
- Health insurance
- Training and access to certification vouchers
- Work-life balance initiatives
- Referral program
- Birthday off
- Give back day – enjoy a day to give back to society!
Apply here: https://zrec.eu/MOmMa?source=CareerSite or send your updated CV to with the reference ZR_51_JOB