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Our client, a global biopharmaceutical leader, is seeking a DT System Expert to join their team in the Walloon region . As the DT System Expert, you will play a crucial role in ensuring the compliance and data enablement of IT platforms.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the DT System Expert will be varied however the key duties and responsibilities are as follows:
1. Support Health IT and data enablement compliance of IT platforms.
2. Collaborate with QA, Business SMEs, and Validation SMEs to write URS, FS, data flow diagrams, and other validation deliverables.
3. Prepare testing protocols (IQ/OQ/PQ), execute testing, and write testing reports.
4. Conduct risk assessments (Functional and Data Integrity) and document and track deviations and CAPAs.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the DT System Expert we are looking to identify the following on your profile and past history:
1. Relevant degree in biochemistry, bioengineering, pharmacy, sciences data management, or related fields.
2. Proven industry experience in qualification/validation in a GMP environment and familiarity with standards and norms (GAMP5, V-model, GxP, 21 CFR Part 11, Data integrity).
3. A working knowledge and practical experience with compliance, quality, and validation in a pharmaceutical environment.
Key Words:
DT System Expert / Health IT / data enablement / compliance / validation / URS / FS / IQ/OQ/PQ / risk assessments / CAPAs / GMP / GAMP5 / V-model / GxP / 21 CFR Part 11 / Data integrity / Collibra / Aetion / SAS
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Our client, a global biopharmaceutical leader, is seeking a DT System Expert to join their team in the Walloon region . As the DT System Expert, you will play a crucial role in ensuring the compliance and data enablement of IT platforms.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the DT System Expert will be varied however the key duties and responsibilities are as follows:
1. Support Health IT and data enablement compliance of IT platforms.
2. Collaborate with QA, Business SMEs, and Validation SMEs to write URS, FS, data flow diagrams, and other validation deliverables.
3. Prepare testing protocols (IQ/OQ/PQ), execute testing, and write testing reports.
4. Conduct risk assessments (Functional and Data Integrity) and document and track deviations and CAPAs.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the DT System Expert we are looking to identify the following on your profile and past history:
1. Relevant degree in biochemistry, bioengineering, pharmacy, sciences data management, or related fields.
2. Proven industry experience in qualification/validation in a GMP environment and familiarity with standards and norms (GAMP5, V-model, GxP, 21 CFR Part 11, Data integrity).
3. A working knowledge and practical experience with compliance, quality, and validation in a pharmaceutical environment.
Key Words:
DT System Expert / Health IT / data enablement / compliance / validation / URS / FS / IQ/OQ/PQ / risk assessments / CAPAs / GMP / GAMP5 / V-model / GxP / 21 CFR Part 11 / Data integrity / Collibra / Aetion / SAS
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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