Biotech NPI QC Analyst - Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site Based
Pay: €30 - €35 per hour
Experience: 3+ years
Visa: EU passport or Stamp 4 visa required
Job Description
A leading international Biotechnology company operates 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 gain experience in Ireland's leading aseptic manufacturing plant.
Responsibilities
* Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
* 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.
* 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.
Requirements
Bachelor's degree in a science discipline.
2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
Strong background in Chemistry and Analytical testing is required.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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
Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information
Communication skills (verbal and written) at all levels
Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
Demonstrated ability to work independently and deliver right first-time results
Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
Auditing documentation and operation process
Package
Contract role - Hourly rate €30 - €35 per hour
Minimum 12 month contract