Job Details: QC Documentation Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QC Documentation Specialist
QC Documentation Specialist

An opportunity has arisen for a QC Documentation Specialist within a
Cork based pharmaceutical multinational. The success candidate will
provide an effective document control system by performing issuance
and reconciliation cGMP documentation to support product testing. You
will be responsible for the control, distribution and archiving of
cGMP documentation throughout its lifecycle providing a robust quality
focused system.

Key responsibilities:

* Provides to the site knowledge and experience in Quality
Documentation Systems.

* Responsible for the QC Labs Documentation System including Issuance,
reconciliation, storage, archiving and retrieval of cGMP documentation
to support the testing of products.

* Uses knowledge to improve Quality Documentation Systems, solve
problems, provide continuous improvement and execute tasks.

* Provides compliance contribution to project teams.

* Complete documentation audits.

* Understands and applies regulatory / compliance requirements to
their role together with remaining current on upcoming regulatory and
compliance changes.

* Responds to non-standard requests from customer needs.

* Makes decisions within guidelines and policies which impact own
priorities and allocation of time to meet deadlines.

* Ensures supply of high quality product through the implementation
and oversight of the Quality Documentation System for the QC Labs.

* Champion the highest Quality and Compliance standards for QC Labs.

* Ensure highest safety standards.

Required:

* A qualification in a quality discipline is desired with **Apply on
the website** years pharmaceutical / documentation experience.

* Experience in a similar regulated documentation role is strongly
preferred.

* cGMP documentation control SME knowledge, from both operational and
educational experience, is required.

* Must possess excellent communication skills (verbal & written). Must
have excellent organizational (Time Management) skills, attention to
detail and computer skills including Excel, Word and Sharepoint. Be
able to work as a flexible member of a Quality team QC Documentation Specialist

An opportunity has arisen for a QC Documentation Specialist within a
Cork based pharmaceutical multinational. The success candidate will
provide an effective document control system by performing issuance
and reconciliation cGMP documentation to support product testing. You
will be responsible for the control, distribution and archiving of
cGMP documentation throughout its lifecycle providing a robust quality
focused system.

Key responsibilities:

* Provides to the site knowledge and experience in Quality
Documentation Systems.

* Responsible for the QC Labs Documentation System including Issuance,
reconciliation, storage, archiving and retrieval of cGMP documentation
to support the testing of products.

* Uses knowledge to improve Quality Documentation Systems, solve
problems, provide continuous improvement and execute tasks.

* Provides compliance contribution to project teams.

* Complete documentation audits.

* Understands and applies regulatory / compliance requirements to
their role together with remaining current on upcoming regulatory and
compliance changes.

* Responds to non-standard requests from customer needs.

* Makes decisions within guidelines and policies which impact own
priorities and allocation of time to meet deadlines.

* Ensures supply of high quality product through the implementation
and oversight of the Quality Documentation System for the QC Labs.

* Champion the highest Quality and Compliance standards for QC Labs.

* Ensure highest safety standards.

Required:

* A qualification in a quality discipline is desired with **Apply on
the website** years pharmaceutical / documentation experience.

* Experience in a similar regulated documentation role is strongly
preferred.

* cGMP documentation control SME knowledge, from both operational and
educational experience, is required.

* Must possess excellent communication skills (verbal & written). Must
have excellent organizational (Time Management) skills, attention to
detail and computer skills including Excel, Word and Sharepoint. Be
able to work as a flexible member of a Quality team

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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