Job Details: Technical Writer


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.
Technical Writer


Are you a Junior/Graduate technical writer? 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.



Junior/Graduate Technical Writer - Production - 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 activities performed in the role of Production Technical Writer include:Develop, review and update production Standard Operating Procedures.

Develop, review and update master/generic batch records, bills of materials etc.

Control the flow of documentation within the project team. Controller for generating, authoring, reviewing, tracking and approving cGMP documentation on EDMQ.

Operations point of Contact for drafting, updating and closing Non Conformance investigations and Change Controls. Complete Production Corrective Action Tracking commitments.

Prepare and track Production Change Notification Requests

Involvement in projects as part of continuous process improvement and / or troubleshooting, including

Liaison with EBR process improvement team to troubleshoot and develop new ways of working

Liaison with site training teams to enhance and develop the site procedures

Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP?s, batch documentation and licences.

Liaise with Technical Services regarding documentation changes in an effective and timely manner.

Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP?s for submission to the production Team Leader.

Provide technical and clerical support to the production team in the preparation of documentation, collation of data and tracking of investigations

Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.



Requirements:

? Educated to degree level or equivalent.

? High level of competency on Microsoft Word

? Experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.

? Experience of EDMQ a distinct advantage



Package:

Contract rate of 20 - 25 euro per hour

Minimum Contract duration: 12 months



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 karen@jobcontax.com or phone +353-1-7978720

Click to connect with Karen on LinkedIn



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Amgen Jobs in Ireland

Are you a Junior/Graduate technical writer? 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.



Junior/Graduate Technical Writer - Production - 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 activities performed in the role of Production Technical Writer include:Develop, review and update production Standard Operating Procedures.

Develop, review and update master/generic batch records, bills of materials etc.

Control the flow of documentation within the project team. Controller for generating, authoring, reviewing, tracking and approving cGMP documentation on EDMQ.

Operations point of Contact for drafting, updating and closing Non Conformance investigations and Change Controls. Complete Production Corrective Action Tracking commitments.

Prepare and track Production Change Notification Requests

Involvement in projects as part of continuous process improvement and / or troubleshooting, including

Liaison with EBR process improvement team to troubleshoot and develop new ways of working

Liaison with site training teams to enhance and develop the site procedures

Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP?s, batch documentation and licences.

Liaise with Technical Services regarding documentation changes in an effective and timely manner.

Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP?s for submission to the production Team Leader.

Provide technical and clerical support to the production team in the preparation of documentation, collation of data and tracking of investigations

Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.



Requirements:

? Educated to degree level or equivalent.

? High level of competency on Microsoft Word

? Experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.

? Experience of EDMQ a distinct advantage



Package:

Contract rate of 20 - 25 euro per hour

Minimum Contract duration: 12 months



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 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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