Job Details: Quality Assurance Specialist


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
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.
Quality Assurance Specialist


Are you an Senior Quality Assurance Specialist with experience on Pharmaceuticals or Biotechnology plants? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



Senior Quality Assurance Specialist - Amgen - Dublin



Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.



Job Description


The successful candidate will report to the Senior Manager QA will be reponsible for the following activities:

Supervise systems associated with Site Quality Review Team.

Acts as QA contact on New Product Introduction Technical Transfer Team

Reviews and approve Master Batch Records.

Write, review and approve Standard Operating Procedures as applicable.

Review and approve bills of material.

Review and approve validation documentation

Review and approve change controls

Provide Quality support for the investigation of all classes of Non Conformances (NCs)

Review and approve all NCs for closure ensuring compliance with appropriate documentation

Participate in appropriate NC related root cause analysis

Collaborate with CAPA owners to ensure CAPA actions address root cause and implementation plan dates are achievable

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

Ensures that both self and staff operate in a safe manner as defined in the safety statement prepared by the Environmental Health and Safety Department.

They will perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.

Support Lean Transformation and Operational Excellence initiatives and participate in team meetings (i.e. Kaizen; Work Center Teams; etc)

Perform all activities in compliance with Amgen safety standards

Ensure all GMP compliance training is up to date before performing GMP activities


Requirements:

A third level qualification in Science, Engineering or a relevant Quality discipline.

Minimum 5 years experience in a similar role.



Package:

Minimum 6 month contract

Rate ?35 - ?40 per hour

Overtime at 1.5



Contact:

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720

Click to connect with Karen on LinkedIn



Similar Jobs

Amgen Jobs in Ireland

Are you an Senior Quality Assurance Specialist with experience on Pharmaceuticals or Biotechnology plants? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



Senior Quality Assurance Specialist - Amgen - Dublin



Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.



Job Description


The successful candidate will report to the Senior Manager QA will be reponsible for the following activities:

Supervise systems associated with Site Quality Review Team.

Acts as QA contact on New Product Introduction Technical Transfer Team

Reviews and approve Master Batch Records.

Write, review and approve Standard Operating Procedures as applicable.

Review and approve bills of material.

Review and approve validation documentation

Review and approve change controls

Provide Quality support for the investigation of all classes of Non Conformances (NCs)

Review and approve all NCs for closure ensuring compliance with appropriate documentation

Participate in appropriate NC related root cause analysis

Collaborate with CAPA owners to ensure CAPA actions address root cause and implementation plan dates are achievable

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

Ensures that both self and staff operate in a safe manner as defined in the safety statement prepared by the Environmental Health and Safety Department.

They will perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.

Support Lean Transformation and Operational Excellence initiatives and participate in team meetings (i.e. Kaizen; Work Center Teams; etc)

Perform all activities in compliance with Amgen safety standards

Ensure all GMP compliance training is up to date before performing GMP activities


Requirements:

A third level qualification in Science, Engineering or a relevant Quality discipline.

Minimum 5 years experience in a similar role.



Package:

Minimum 6 month contract

Rate ?35 - ?40 per hour

Overtime at 1.5



Contact:

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720

Click to connect with Karen on LinkedIn



Similar Jobs

Amgen Jobs in Ireland

We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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