Job Details: CSV Lead


JobsIreland
Jervis Street
Dublin 1
CSV Lead
About the Role:

Zenith Technologies is looking to hire a QA IT (CSV) Lead to join our
client&#**Apply on the website**;s Biopharmaceutical site in Dunboyne,
Co.Meath.

QA IT (CSV) Lead will design and manage all compliance activities for
the assigned GxP regulated computerized systems throughout each
system&#**Apply on the website**;s lifecycle.

He/She will provide and co-ordinate QA IT oversight and support for
the computerised systems that are being implemented as part of a major
capital project to ensure compliance with regulatory expectations and
company Computer Systems Validation (CSV), System Development
Lifecycle (SDLC), Cyber Security and Data Integrity requirements. The
QA IT (CSV) Lead will actively contribute to the overall validation
strategy and liaise with relevant technical and business units to
drive consistent and compliant approach across the systems.

Responsibilities:

• Providing independent quality review and approval of system
lifecycle documentation, such as plans, requirements, risk
assessments, protocols and reports for GxP systems, including but not
limited DCS, automated equipment, MES and associated local
infrastructure.

• Providing input into the validation strategy for computerised
systems, including leveraging approach.

• Liaising with technical and business units to drive consistency
and understanding of compliance expectations.

• Ensuring adherence to relevant regulations and company procedures,
including DI.

• Providing timely and pro-active QA IT support and guidance to
facilitate project timelines.

• Actively working with QA IT colleagues within the site as well as
the global QA IT organisation to ensure alignment with the current
site and other projects.

• Escalating any potential compliance issues in a timely manner.

Qualifications & Requirements:

* Min. 7 years of experience in QA IT/CSV, CSV and/or a similar role
in the pharmaceutical industry.

* Project experience in a senior specialist / lead position.

* Strong compliance background

* DeltaV, OSI PI and PAS-X experience

* Experience with ISA S**Apply on the website** and S**Apply on the
website** standards

* Experience of Testing GAMP Category 3, 4 & 5 systems & knowledge of
CFR **Apply on the website** Part**Apply on the website**

* Excellent knowledge of relevant regulations and industry standards.

* Proven ability to meet timelines, prioritise tasks and engage with
stakeholders.

* Excellent communication skills.

* Project management experience will be an advantage

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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