Job Details: QA CSV Engineer


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QA CSV Engineer
MAIN DUTIES & RESPONSIBILITIES:

* Ensure computer system validation activities completed are compliant
with internal procedures and external regulations and standards.

* Review and approve documents prepared by project teams, other
departments and contractor organizations (e.g. protocols, reports,
change controls)

* Assist in development of validation strategy and validation plan for
computer system validations.

* Assist in resolution of deviations/ exceptions during qualification
activities

* Assist with change control activities in accordance with site
procedures

* Attend identified training required to fulfil the role of QA
Computer System Validation Engineer

* Support the QA Validation team leader in driving improvements within
the Validation and Change Control processes to streamline the
validation activities associated with system changes and new
technology development.

* Participate in cross-functional teams as required.

EXPERIENCE ESSENTIAL:

* Hons. Degree Quality/ Manufacturing / Engineering / Science or
related field

* Minimum 2 years of related industry experience.

* Minimum of 3 years&#**Apply on the website**; experience with
automated system development or operation.

* Strong knowledge of Quality systems (FDA/ISO) within a regulated
environment including **Apply on the website**CFR Part **Apply on the
website**.

* Strong knowledge of system development life cycle and GAMP.

* Validation experience with automated manufacturing system.

DESIRABLE:

* In depth knowledge of **Apply on the website** CFR **Apply on the
website**, **Apply on the website** CFR **Apply on the website**, ISO
**Apply on the website** and European regulations associated with the
medical device industry

* High understanding of GMP, Compliance, Validation practices
including the system development life cycle and regulatory
expectations

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful
treatment MAIN DUTIES & RESPONSIBILITIES:

* Ensure computer system validation activities completed are compliant
with internal procedures and external regulations and standards.

* Review and approve documents prepared by project teams, other
departments and contractor organizations (e.g. protocols, reports,
change controls)

* Assist in development of validation strategy and validation plan for
computer system validations.

* Assist in resolution of deviations/ exceptions during qualification
activities

* Assist with change control activities in accordance with site
procedures

* Attend identified training required to fulfil the role of QA
Computer System Validation Engineer

* Support the QA Validation team leader in driving improvements within
the Validation and Change Control processes to streamline the
validation activities associated with system changes and new
technology development.

* Participate in cross-functional teams as required.

EXPERIENCE ESSENTIAL:

* Hons. Degree Quality/ Manufacturing / Engineering / Science or
related field

* Minimum 2 years of related industry experience.

* Minimum of 3 years&#**Apply on the website**; experience with
automated system development or operation.

* Strong knowledge of Quality systems (FDA/ISO) within a regulated
environment including **Apply on the website**CFR Part **Apply on the
website**.

* Strong knowledge of system development life cycle and GAMP.

* Validation experience with automated manufacturing system.

DESIRABLE:

* In depth knowledge of **Apply on the website** CFR **Apply on the
website**, **Apply on the website** CFR **Apply on the website**, ISO
**Apply on the website** and European regulations associated with the
medical device industry

* High understanding of GMP, Compliance, Validation practices
including the system development life cycle and regulatory
expectations

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful
treatment

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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