Job Details: QA Specialist - Biotech PQA - Dublin


104 Upper Drumcondra Road,
Dublin 9
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
QA Specialist - Biotech PQA - Dublin
Are you a Senior PQA Associate with 4+ years of biopharmaceutical

Do you have knowledge and experience in managing Root Cause Analysis /
Deviation investigations

If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.



Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
South Dublin. 

The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into
Ireland&# *;s leading aseptic manufacturing

The Quality Assurance (QA) Senior Associate will report to a QA
Manager and is a core member of the site Quality Assurance team. 

Quality point of contact for Plant Quality Assurance (PQA).  

The site is focused oncontinuous improvement of all work processes and
practices, therefore in addition to

routine Quality Assurance duties, QA Snr Associates may be asked to
carry out additional work functions to support site continuous
improvement activities. This is a */7 shift
role required to support manufacturing operations.

The Plant QA team structure is one group responsible for oversight of
aseptic manufacturing (Formulation and Fill) and for oversight of the
Inspection and Packaging operation.

Key Responsibilities:

Perform all activities in compliance with Amgen safety standards and

standard operating procedures.

Observe and provide real-time quality oversight and support for

manufacturing on the floor.

Perform purposeful presence on the floor audits.

Perform manual visual inspection AQL audits of vials and syringes.

Perform QA reserve sample inspections as part of the annual reserve

inspection program and in support of customer complaint investigations

Certification of defect panels.

Provide quality support for triage and investigation of all classes of


Review/approve deviations for closure ensuring compliance with


Review/approve production batch records, and associated documentation

preparation for qualified person disposition activities.

Provides training and advice to staff in order for them to perform
their desired


Write, review and approve standard operating procedures in accordance

our clients policies.

Support continuous improvement and operational excellence initiatives

Any other tasks/projects assigned as per manager’s request.

Basic Qualifications & Experience:

University degree. Engineering or Science related discipline

Relevant experience (4 years +) working in the pharmaceutical or

biotechnology industry or other combination of experience and

background that may otherwise satisfy the requirements of the role.

Preferred Qualifications & Experience:

Excellent written and verbal communication skills

Experience working with dynamic cross-functional teams and proven
abilities in decision making

Strong organizational skills, including ability to follow assignments
through to completion

Demonstrated ability in problem solving and experience in managing

Cause Analysis / Deviation investigations

Internal Use Only General and Administrative

Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues

Operational Excellence experience


Competitive salary depending on experience 

We need : English (Good)

Type: Permanent
Payment: Negotiable
Category: Construction

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Please Provide a Cover in the English Language.
CV: (*) 
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