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
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