Job Details: Quality Assurance IT Specialist - QA / CSV / SDLC / Pharma / Biotech


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Quality Assurance IT Specialist - QA / CSV / SDLC / Pharma / Biotech
We are one of the largest, best known Pharmaceutical companies in the
industry and our products are known globally.

We are looking to recruit an Experienced QA IT Specialist to join us
on an initial **Apply on the website** month contract.

You will be responsible for the independent oversight and support for
the site computerised systems to ensure compliance with regulatory
expectations and company Computer Systems Validation (CSV), System
Development Lifecycle (SDLC), Cyber Security and Data Integrity
requirements. This will include supporting day-to-day activities, such
as system changes, investigations and periodic reviews, and multiple
system upgrades across various business units so it is essential the
post holder has previous experience in a similar role within the
pharmaceutical industry.

Responsibilities:

* Providing independent quality review and approval of system
lifecycle documentation, such as plans, requirements, risk
assessments, protocols and reports.

* Providing independent quality review and approval of system changes.

* Supporting and approving computerised systems investigations and
deviations.

* Ensuring consistent approach to qualification, change and deviation
management across systems.

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

* Where required, engaging with QA IT teams from other sites to
standardise and align approach to computerised systems compliance.

Experience:

* Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role
in the pharmaceutical industry.

* Working 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.

* Infrastructure, OSI PI and PAS-X experience will be an advantage.

Please press apply now to submit your application. Alternatively, if
you would like further information on this position or other positions
win a similar sector, please feel free to contact our team on (phone
number removed) for a confidential conversation.

We are an equal opportunities Business. We welcome applications from
all suitably qualified candidates regardless of their race, sex,
disability, religion/belief, sexual orientation or age.

Each company within the Planet Equity Group is a "data controller".
This means that we are responsible for deciding how we hold and use
personal information about you in line with GDPR guidelines. Full
details regarding how we hold your data is available within our
Privacy Notice accessible We are one of the largest, best known Pharmaceutical companies in the
industry and our products are known globally.

We are looking to recruit an Experienced QA IT Specialist to join us
on an initial **Apply on the website** month contract.

You will be responsible for the independent oversight and support for
the site computerised systems to ensure compliance with regulatory
expectations and company Computer Systems Validation (CSV), System
Development Lifecycle (SDLC), Cyber Security and Data Integrity
requirements. This will include supporting day-to-day activities, such
as system changes, investigations and periodic reviews, and multiple
system upgrades across various business units so it is essential the
post holder has previous experience in a similar role within the
pharmaceutical industry.

Responsibilities:

* Providing independent quality review and approval of system
lifecycle documentation, such as plans, requirements, risk
assessments, protocols and reports.

* Providing independent quality review and approval of system changes.

* Supporting and approving computerised systems investigations and
deviations.

* Ensuring consistent approach to qualification, change and deviation
management across systems.

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

* Where required, engaging with QA IT teams from other sites to
standardise and align approach to computerised systems compliance.

Experience:

* Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role
in the pharmaceutical industry.

* Working 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.

* Infrastructure, OSI PI and PAS-X experience will be an advantage.

Please press apply now to submit your application. Alternatively, if
you would like further information on this position or other positions
win a similar sector, please feel free to contact our team on (phone
number removed) for a confidential conversation.

We are an equal opportunities Business. We welcome applications from
all suitably qualified candidates regardless of their race, sex,
disability, religion/belief, sexual orientation or age.

Each company within the Planet Equity Group is a "data controller".
This means that we are responsible for deciding how we hold and use
personal information about you in line with GDPR guidelines. Full
details regarding how we hold your data is available within our
Privacy Notice accessible

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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Please Provide a Cover in the English Language.
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