Job Details: QA Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QA Specialist
JOB DESCRIPTION

Lead site cross-functional Kaizens and continuous improvement
initiatives from conception to closure, with specific focus on Quality
and Laboratory driven improvements.

Participate in Quality Management System Harmonisation activities.

Manage the calibration of GMP Service Providers in QC Laboratory

Responsible for completion of Data integrity admin checks

Represent Quality in support of Deviations, Change Controls, CAPAs,
etc., including active participation in investigations and problem
resolution.

Complete batch record review on the shop floor.

Perform API Product Release.

Prepare, review data and reports including quarterly and annual
product quality review reports.

Participate in the internal auditing program.

Lead method development and validation initiatives.

Edit, review and approve GMP documents.

Ensure that EHS roles and responsibilities are complied with as per
the requirements of the site Safety Statement

Perform other related duties as assigned from time to time based on
company needs.

Minimum of a Bachelor Degree in Science or related pharmaceutical
discipline

Minimum 3 years experience within the pharmaceutical industry.

Desirable evidence of Continuous Professional Development.

Understanding of EU GMP Complexity.

A proven identifiable track record of success in a similar
environment.

Good organizational skills and attention to detail.

Requires good written, verbal and interpersonal communication skills
and the ability to effectively interact cross functionally.

Ability to prioritize, manage multiple tasks, and meet deadlines

Ability to learn and utilize computerized systems for daily
performance of tasks.

Strong Interpersonal Skills

Strong Functional / Technical skills

Ambition coupled with Ability

Creativity

Decision Quality

Managing & Measuring Work

Managerial Courage

Learning / Change Agility

Drive for Results

Continuous Improvement mindset
JOB DESCRIPTION

Lead site cross-functional Kaizens and continuous improvement
initiatives from conception to closure, with specific focus on Quality
and Laboratory driven improvements.

Participate in Quality Management System Harmonisation activities.

Manage the calibration of GMP Service Providers in QC Laboratory

Responsible for completion of Data integrity admin checks

Represent Quality in support of Deviations, Change Controls, CAPAs,
etc., including active participation in investigations and problem
resolution.

Complete batch record review on the shop floor.

Perform API Product Release.

Prepare, review data and reports including quarterly and annual
product quality review reports.

Participate in the internal auditing program.

Lead method development and validation initiatives.

Edit, review and approve GMP documents.

Ensure that EHS roles and responsibilities are complied with as per
the requirements of the site Safety Statement

Perform other related duties as assigned from time to time based on
company needs.

Minimum of a Bachelor Degree in Science or related pharmaceutical
discipline

Minimum 3 years experience within the pharmaceutical industry.

Desirable evidence of Continuous Professional Development.

Understanding of EU GMP Complexity.

A proven identifiable track record of success in a similar
environment.

Good organizational skills and attention to detail.

Requires good written, verbal and interpersonal communication skills
and the ability to effectively interact cross functionally.

Ability to prioritize, manage multiple tasks, and meet deadlines

Ability to learn and utilize computerized systems for daily
performance of tasks.

Strong Interpersonal Skills

Strong Functional / Technical skills

Ambition coupled with Ability

Creativity

Decision Quality

Managing & Measuring Work

Managerial Courage

Learning / Change Agility

Drive for Results

Continuous Improvement mindset


We need : English (Good)

Type: Permanent
Payment:
Category: Others

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