CSV Data Integrity Assessor

Boxmeer, Boxmeer (NLD)
Negotiable
3 Months
Start date: 04 Jan 21
3 positions available
Ref: MSD

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Skills

21 cfr part 11
data integrity
compliance
sop
protocols
SDLC

Job description Posted 16 December 2020

CSV, Data Integrity Gap Assessor

Responsibilities & Competencies:

· The Work involved is twofold, initially the Gap Assessor need to familiarise themselves with the entire SDLC Package, from QAP, URS/RS, IIP, DQ, FAT, SAT, IOQ, RAN/QASR for the assigned DP System.

· Reviewed both executed SAT’s/IOQ’s and ensure that all Incidents and attachments cross referenced within the executed documents/Test Protocols are present

· Compile the executed Protocols, so it can be scanned accordingly. So, these resources need to be on the Site at Boxmeer.

· Once scanned, complete one final review to ensure all scanned document is clearly legible, and all pages are present and scanned in sequential order

· Submit it to the relevant Resource for True certification.

· Review the QAP for DP Systems under consideration and check for the presence of all documentation that was deemed required in this QAP and in accordance to SDLC-SOP-09 primarily and other associated MSD SDLC SOP’s

Commence the Gap Assessment for the DP system once all the above listed items has been achieved.

You have:

21 CFR part 11

· Familiar with the concept of ALCOA principle and a strong understanding of the latest Data Integrity Requirements associated with the Automation and IT elements of these DP systems

· Capable of articulating, and documenting Gaps within a defined Template

· Have good Problem-solving abilities, as well as being a Solution Provider

· Proactive in managing the Daily, weekly workload and reporting metrics on progression/completion. In addition to seeking out all the necessary Training and access to the Different Systems in order to review all executed documents and complete the Gap Assessment thoroughly

· Have a Strong Focus on Compliance and adherence to Human Health Global and Local standards and procedures.

· Be a good Communicator and work with all Resources assigned to the Project Shield Team to achieve a common goal, respecting all Technical, compliance and other points of view.

· In all instance “Logic must prevail” and striking a Balance, that can close the Gap and meeting Compliance either immediately or later is essential