Offer summary

Qualifications:

Master's degree in Bio-engineering, Chemistry, Pharmacy, or related fields., Experience in biopharmaceutical or development sciences and validation consulting for computer systems., Proficiency in English and MS Office, with preferable experience in SAS Life Science Analytics Framework., Attention to detail and ability to work autonomously..

Key responsabilities:

Write software validation deliverables and manage document lifecycles in EDMS.

Ensure compliance with methodologies and SOPs, and manage project validation deliverables.

Assist in writing and reviewing Validation SOPs and templates, and resolve compliance issues.

Create and manage quality events, ensuring effective communication with stakeholders.

Job description

This is a remote position.

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.