/ Engineering / Validation gained within a biotech, pharma or health
care organisation?
This is a contract role based in Dun Laoghaire, Dublin.
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.
TECHNICAL WRITER - BIOTECH PLANT - DUBLIN
JOB DESCRIPTION
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
plant.
You will be responsible for owning and managing change controls
critical to site development and managing the operational
documentation updates as required by each project.
Develop/ Update and maintain Operations procedures in accordance with
site and corporate requirements.
Serve as a document owner.
Assist in generation of training materials and may assist in providing
training on scientific or technical aspects of the process.
Liaise with Manufacturing/Inspection/Engineering regarding
documentation changes in an effective and timely manner
Develop protocols for execution in Manufacturing & Inspection in
support of change controls, non-conformances & troubleshooting
investigations with support from relevant SMEs
Involvement in projects as part of continuous process improvement and
/ or troubleshooting
Ownership and management of change controls as required
Issuance and updates of paper batch records in line with production
schedule
Liaise with Quality Assurance to ensure that GMP standards are
maintained in line with current OS
Partner with Operations lead/appropriate SME to ensure updates are
correct and aligned with project deliverables/ timelines.
Perform document trending upon project completion to identify keys
issues/mistakes in document processing.
Support data verification of Operations owned protocols reports and
risk assessments.
Support the production support team in reducing document turnaround
times
Use specified software packages and standard procedures, responsible
for compiling and maintaining all relevant documentation including
SOPs
Provide technical and clerical support to the manufacturing,
inspection & engineering teams in the preparation of documentation,
collation of data and tracking of SOPs
Ensure Non-conformance are triage within the established goal and
serve as a deviation owner for minor deviations.
Own corrective /preventative actions and effectiveness verification.
Support execution of C&Q, characterisation, functional testing
protocols as required by project.
NOTE: This may require flexible working hours.
REQUIREMENTS
Bachelor’s degree in a Science or Engineering discipline.
3+ years of experience in
Chemistry/Microbiology/Engineering/Validation gained within a biotech,
pharma or health care organization
Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products an advantage
Strong Project Management and organizational skills, including ability
to follow assignments through to completion
Excellent verbal and written communication skills: Strong Technical
writing skills for GMP documentation (e.g., investigations,
procedures, change controls) and good Presentation skills
Escalate issues professionally and in a timely manner
Ensures compliance within regulatory environment
Demonstrated ability to work independently and deliver right
first-time results under minimal direction
Experience participating in and leading cross-functional teams
Experience in managing multiple, competing priorities in a fast-paced
environment
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 40 - 45 Per Hour
Category: Construction
