analytical techniques including but not limited to Cell-Based Potency
Bioassays, Immunoassays, Cell Culture and Aseptic Technique?
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.
QC ANALYST - BIOTECH NPIS - 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.
Under minimal supervision, responsible for one or more of the
following activities in QC including analytical testing,
characterization, sample and data management.
Contributes to team by ensuring the quality of the tasks/services
provided by self
Contributes to the completion of milestones associated with specific
projects or activities within team
This role will support QC and manufacturing operations, as such some
extended hours and weekend work flexibility may be necessary as
required.
With a high degree of technical flexibility, work across diverse areas
within QC
Plan and perform analyses with great efficiency and accuracy.
Plan and perform multiple, complex routine/ non-routine methods and
procedures and a large variety of assays.
Report, evaluate, back-up/archive, trend and approve analytical data.
Troubleshoot, solve problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents.
May train others as necessary
Participate in audits, initiatives and projects that may be
departmental or organizational in scope.
Write protocols and perform assay validation and equipment
qualification/ verification.
Introduce new techniques to the lab, including method transfers,
reports, validations and protocols.
May contribute to regulatory filings.
May conduct lab investigations as necessary.
Evaluate lab practices for compliance on a continuous basis.
Approve lab results
May represent the department/organization on various teams
May interact with outside resources.
Create APPX data files and randomisation memo to facilitate data
analysis.
LIMS data coordination of commercial and import testing on site where
applicable
May provide technical guidance. May contribute to regulatory filings.
May represent the department/organization on various teams. May train
others.
May interact with outside resources
QC Representative for NPI activities and routine Product meetings
Assist with activities related to QC projects and/or QC tasks within
Site projects
Plan and perform non-core testing related to NPI activities
Manage all sample management activities related to NPI activities
throughout the site
Create/own and approve protocols, sample plans, SOP and documentation
related to NPI
QC Representative responsible for Method Validation and Transfers
co-ordination and readiness
Responsible for their own training and safety compliance.
Sample shipments and temperature monitoring activities for NPI
activities
LIMS data coordination of non-core (NPI) activities.
REQUIREMENTS
Bachelor’s degree in a Science related field is required.
5+ years of biopharmaceutical QC experience or related quality control
or GMP laboratory experience in the pharmaceutical or medical device
industry,
Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products.
Strong background in Chemistry and Analytical testing is required.
Knowledge:
Understanding and application of principles, concepts, theories, and
standards of GMP QC analytical laboratories.
Deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance
issues and/or scientific discovery
Problem Solving:
Applies analytical skills to evaluate and interpret complex
situations/ problems using multiple sources of information
Qualitative information
Quantitative research
Trend data
Anticipates and prevents potential problems
PACKAGE
Contract role
Hourly Rate € * - € *
per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 25 - 32 Per Hour
Category: Construction
