Job Details: QC Associate


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QC Associate
QC Associate

An opportunity has arisen for a QC Associate within the quality
department of a leading biopharmaceutical multinational based in
Dublin.

The successful candidate will be responsible for sample management
activities, data management and equipment maintenance. The role will
ideally suit someone looking to move away from a lab testing role.

Responsibilities

? Execute sample management activities across the site - sample
distribution, LIMS logging

? Perform Stability Program related activities such as pulling
stability samples, study initiations.

? Create/own and approve protocols, sample plans, SOPs, training
manuals.

? Perform SAP, LIMS and CIMS functions/ transactions within the
sample management remit

? Out of hours responder for sample management equipment (fridges
/freezers / incubators)

? Responsible for their own training and safety compliance.

? Sample shipments and temperature monitoring activities.

? LIMS logging + data coordination of commercial and import batches.

? Management and maintenance of the site inventory of Reference
Standards, Assay Controls, Training and Verification samples within an
electronic management system

Qualifications and Experience

? Bachelor&#**Apply on the website**;s degree in a Science related
field is required.

? 5+ years of biopharmaceutical QC experience or related quality
control or GMP laboratory experience in the pharmaceutical or medical
device industry, where 2 - 3 years of specific sample management/
stability programme experience is desirable.

? Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products

? Understanding and application of principles, concepts, theories
and standards of GMP QC analytical laboratories.

? Knowledge of related regulatory/industry considerations,
compliance issues and/or scientific discovery

? Communication skills (verbal and written) at all levels QC Associate

An opportunity has arisen for a QC Associate within the quality
department of a leading biopharmaceutical multinational based in
Dublin.

The successful candidate will be responsible for sample management
activities, data management and equipment maintenance. The role will
ideally suit someone looking to move away from a lab testing role.

Responsibilities

? Execute sample management activities across the site - sample
distribution, LIMS logging

? Perform Stability Program related activities such as pulling
stability samples, study initiations.

? Create/own and approve protocols, sample plans, SOPs, training
manuals.

? Perform SAP, LIMS and CIMS functions/ transactions within the
sample management remit

? Out of hours responder for sample management equipment (fridges
/freezers / incubators)

? Responsible for their own training and safety compliance.

? Sample shipments and temperature monitoring activities.

? LIMS logging + data coordination of commercial and import batches.

? Management and maintenance of the site inventory of Reference
Standards, Assay Controls, Training and Verification samples within an
electronic management system

Qualifications and Experience

? Bachelor&#**Apply on the website**;s degree in a Science related
field is required.

? 5+ years of biopharmaceutical QC experience or related quality
control or GMP laboratory experience in the pharmaceutical or medical
device industry, where 2 - 3 years of specific sample management/
stability programme experience is desirable.

? Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products

? Understanding and application of principles, concepts, theories
and standards of GMP QC analytical laboratories.

? Knowledge of related regulatory/industry considerations,
compliance issues and/or scientific discovery

? Communication skills (verbal and written) at all levels

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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