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Job Description
Intern - QC Analytical Analyst.
This role will be part of our Testing Self-Directed work team in our state of the art facility Dunboyne, County Meath, Ireland.
• The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
• The Quality Control Analyst intern will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.
• The Quality Control Analyst intern will be responsible for functional testing on in-process drug substance/drug product, final drug products, and stability samples
• The overall responsibility for this role will be to support the Quality Control testing function related to Analytical methods, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.
• Review Analytical Testing data.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Get actively involved by participating in inspections, GEMBA’s and Go-See’s.
• Consistently deliver on specific area Key Performance Indicators.
• Operate to the highest standards of Safety, Quality and Compliance.
• Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs across our site that support our COMMIT culture.
• Contribute to a continuous improvement environment and bring problem solving and troubleshooting capabilities.
• Routinely talk about any safety issues you are concerned about.
• Know the hazards of the tasks you are performing, actively conduct risk assessments for inclusion into operational SOPs.
• Challenge yourself before starting any task and identify safety improvements and be an active
participant of our site safety standards challenging the status quo. If something is out of the
ordinary, or something changes, step back and reassess; if in doubt do not do it.
• Challenge and identify improvements to the safety and environmental programmes on site.
• Ensure you are effectively trained for the work you need to do, challenge the safety training if it is
not effective.
• Promote an environment where everyone speaks up for our culture of safety and looks out for one
another.
• Be part of a motivated and high performing team.
• Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate
with.
• Demonstrate a commitment to learning and personal development.
• Role model the behaviours that creates a culture of dignity and respect.
• Identify improvement opportunities, perform technical troubleshooting and successfully implement
solutions.
• Support the implementation of site strategy and business unit strategy by identifying appropriate initiatives for applicable improvements to the value stream. In some instances, support corporate initiatives and projects as required.
• Support approved projects and continuous improvement initiatives that are in alignment with the site strategies.
• Get actively involved in supporting the implementation of the lean management system.
• Undertake job specific activities:
• On-time completion for one’s own training and to continue professional development and generate expertise in the role.
• Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations, compliance with regulatory authority requirements.
• Play a key role in the roll out and development of standard work processes on-site, continually looking for improvements and operational efficiencies.
• Take part in tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
• Participate in walk-downs of labs.
• Assist in project activities as they arise to maintain and optimize the facility.
Be prepared to answer auditor questions during site walkdowns.
• Testing of all laboratory samples including in-process and developmental samples, product
validation, stability testing.
• Performance of laboratory tests as per written procedure or as per pharmacopoeia.
• Recording of analytical results accurately.
• To act as an end-user for testing input and process changes.
• Operation, qualification, maintenance, calibration, and troubleshooting of laboratory
instruments.
• To maintain written training records.
• To ensure that the laboratory is kept clean, tidy and safe always.
• To report any non-conformance, instrument malfunction, accident or other abnormal
occurrence to immediate superior.
• Ordering, receiving and controlling laboratory chemicals, reagents and consumables.
• Receiving and controlling test samples.
• Reviewing data, reports, and performing peer reviews to ensure compliance with standards;
reports any quality anomalies.
• Following all relevant Standard Operating Procedures.
• Comply with all pertinent regulatory agency requirements.
• May interact with outside customers or functional peer groups.
• Promotes and exhibits company values & policies.
• Ensures new/revised quality system requirements are deployed to the site.
• Observe GLP/cGMP always.
• Encourage new and innovative approaches to improve the value stream.
• Utilise real-time data analytics for making decisions on the value stream improvement intiatives.
• Engage in implementing innovative solutions that drive a high-performance organisational culture
that accommodates rapid growth and highly dynamic expectations ensuring attainment of site
operational and development goals. Engage in other tasks as assigned.
• Create an environment of right first time in everything that we do through a focus on principles
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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