24 Oct
JobContax Recruitment
Quebec City
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
Biotech NPI QC Analyst - Dun Laoghaire, Dublin
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.
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.
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
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
Contact
Karen McHugh is the consultant managing this position.
If you are a Quality Control Analyst interested in roles based in Dublin ,
you can contact Karen by e-mail at *****@jobcontax.com Karen or phone 353 1 9696683 for a confidential chat.
JobContax do not send CVs to clients without candidate permission.
With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Quality Control Analyst in Dublin and Ireland.
Due to the large volume of applications, JobContax may not be able to respond to every individual.s
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▶️ Biotech NPI QC Analyst
🖊️ JobContax Recruitment
📍 Quebec City