Specialist – QA Technical Support NPI Job at Amgen (Dun Laoghaire)

Specialist – QA Technical Support NPI

The Quality Assurance Technical Support Specialist NPI (New Product Introduction...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

University degree in a Science-related discipline
Minimum of 7 years’ relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections
Experience working in aseptic operations, relating to vial and syringe filling
Understanding of principles of Validation and New Product Introduction
Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions)
Strong organizational skills with the ability to manage tasks through to completion
Ability to work independently and remotely with minimum direct supervision
Strong critical thinking and problem-solving abilities
Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration

Job Responsibility

Provide overall quality direction and oversight for key functional areas (i.e. PD, Validation and Operations), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations
Serve as the QA Lead for technology transfer and NPI activities for Aseptic product, providing quality oversight throughout process validation and product lifecycle introduction
Serve as the QA point of contact and decision-maker during validation execution, ensuring adherence to regulatory and internal standards
Lead QA review and approval of technology transfer and validation documentation including process descriptions, Validation Plans, protocols, validation reports, and risk assessments
Lead QA review and approval of SAP BOMs, MBRs and recipes
Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements
Provide quality direction and input for Change Controls, CAPAs, and Deviation Investigations
Support inspection readiness and regulatory audits, representing QA for validation and NPI areas
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Perform all activities in compliance with Amgen safety standards and SOPs

What we offer

Competitive salary structure
Generous Total Rewards Plan for staff and eligible dependents
Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development and career advancement opportunities

Fulltime

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Becoming an apprentice at AxisCLC is an excellent opportunity to gain practical ...

Location

United Kingdom , Liverpool

Salary:

8.00 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

GCSE 4 & above (A-C) in Maths & English or equivalent
Good communication
Presentable
Positive attitude to work
Attention to detail

Job Responsibility

Ensure the effective delivery of service in line with Axis Health and Safety policies and procedures
Ensure and undertake any recording of work and administration required by Axis standards and timescales
Report any Health and Safety issues and outstanding defects to your Supervisor, Contracts Manager, Health and Safety team and Apprentice Co-ordinator
Work as an integral team member with other apprentices, Axis operatives, clients, customers, and tenants
Attend Axis Induction, Health and Safety training, Toolbox talks and College Induction
Undertake multi-trade work to a safe, clean, and high-quality standard
Learn how to cost multi-trade area work with your Axis Mentor, identifying cost reduction methods
Ensure college course attendance is 100% and college absence communicated to your Line Manager and Apprentice Co-ordinator every time you fail to attend college
Ensure that you meet your operative on time daily
Communicate any absence from work as per your contractual terms and conditions

What we offer

Pension scheme and life assurance
Travel Expense Coverage: Enabling all apprentices to travel to/from college and/or apprentice/work-related events
23 days’ holiday + bank holidays
Access to Perkbox (discounts, perks & wellbeing offers)
1 paid volunteer day
Access to Learning and development opportunities: These include financial wellbeing, technical skills and coaching

Fulltime

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Are you looking for that next step in your career, then you've come to the right...

Location

United Kingdom , Shafton

Salary:

7692.30 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Great customer service skills
ideally from a catering or retail background
ability to undergo an enhanced DBS check

Job Responsibility

Working as part of the catering team to provide a friendly, efficient and hygienic service
Assist in the preparation of food and snacks
Counter service and till work
Keeping the kitchen and restaurant areas in a clean and tidy state at all times

What we offer

Free meal supplied on shift
Free qualifications and career development opportunities
Staff discount scheme at over 850 retailers
Monthly opportunities for the best teams to win shopping vouchers
All school holidays off

Parttime

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An exciting opportunity has arisen for a Domestic/Laundry Assistant to join our ...

Location

United Kingdom , Southport

Salary:

12.60 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Caring nature and positive attitude
desire to deliver high standard domestic and laundry service
previous domestic experience preferred
commitment to highest levels of cleanliness, hygiene and appearance
ability to demonstrate compassion and empathy towards older people
team player but able to work on own initiative
dependable and flexible to meet needs of residents and home
alternate weekend availability required

Job Responsibility

Ensuring clean safe environment for residents, visitors and staff
following daily schedule for cleaning
hoovering
dusting
polishing
shampooing carpets
mopping floors
any other duties as required
laundry duties for all clothing and bedding
ensuring everything is labelled and washed according to washing instructions

What we offer

Fortnightly pay
28 days paid annual leave (pro rata)
free uniform
cost of DBS paid
fully paid induction training
£200 refer a friend bonus

Fulltime

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My client, a Professional Services Firm in Boston is hiring a Senior Accounting ...

Location

United States , Boston

Salary:

130000.00 - 150000.00 USD / Year

Robert Half

Expiration Date

Until further notice

Requirements

Degree in Accounting, Finance or related
8+ years of Accounting experience
Professional Services Industry experience highly preferred

Job Responsibility

Report to the Director of Finance and oversee Accounting for the company

What we offer

Bonus
great benefits
growth potential
hybrid working arrangement

Fulltime

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The Senior Mobile Developer (React Native) will play a crucial role in our engin...

Location

Romania , Cluj

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Bachelor’s degree in software engineering-related discipline (preferably in Computer Science)
A minimum of 5-7 years demonstrable experience in Mobile Development
Strong understanding of TypeScript both functional and objected oriented style
3+ years previous experience in working with React Native and NextJS
Building REST based microservices and an understanding of configuring/deploying services to cloud environments
Strong understanding of mobile application architecture best practices (e.g. MVP, MVVM, Flux)
Strong understanding of clean code and clean architecture concepts (e.g. SOLID, Onion)
Strong understanding of at least one layered backend application architecture (e.g. three tier, hexagonal, onion)
Excellent knowledge of test-driven development and testing pyramid
Comfortable pair programming with other developers when needed

Job Responsibility

Building clean, maintainable features and resolving end-to-end issues with an understanding of different possible approaches
Ensuring that the solutions developed and deployed are fit for purpose, provide appropriate business value, adhere to quality standards and align to standard engineering practices
Understanding and contributing to the strategy for the management of technical debt within the team
Analysing and defining test approaches and strategies within your team so that the customer experience is of the highest quality – with an emphasis security, usability and accessibility
Conducting and participating in code reviews with an emphasis on both functional and non-functional requirements, considering, performance, resiliency, maintainability and security
Enthusiastically promoting inspection and adaptation to improve team effectiveness & happiness, supporting changes to enhance processes and culture
Building a culture of mutual respect, collaboration and engagement within the team, coaching, mentoring and supporting less experienced engineers to develop and grow their skills
Undertaking continuous research on relevant application technologies and identify and implement opportunities to incorporate those into the application as appropriate

What we offer

Smooth integration and a supportive mentor
Pick your working style: choose from Remote, Hybrid or Office work opportunities
Projects have different working hours to suit your needs
Sponsored certifications, trainings and top e-learning platforms
Private Health Insurance
Individual coaching sessions or accredited Coaching School
Epic parties or themed events

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Front of House Team Members & Bar Staff play a vital role in creating memorable ...

Location

United Kingdom

Salary:

11.15 - 15.69 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Previous experience in a similar Front of House or Bar role within the catering and hospitality industry is preferred but not essential
A friendly and approachable demeanour with excellent communication skills
Ability to work flexible hours, including evenings and weekends, as required by event schedules
Strong team player with a proactive and positive attitude
Basic knowledge of health and safety practices in hospitality
Ability to work efficiently under pressure in a fast-paced environment

Job Responsibility

Welcome guests warmly and provide outstanding customer service throughout their visit
Serve beverages efficiently and responsibly at the bar, including alcoholic and non-alcoholic drinks
Assist with event setup and breakdown, ensuring the venue is presented to the highest standards
Serve our guests with a smile
Maintain cleanliness and organisation of the bar and front of house areas at all times
Work effectively as part of a team to support colleagues and contribute to a positive working environment
Adhere to all health and safety regulations, including responsible alcohol service policies
Handle customer enquiries and resolve any issues promptly and courteously

What we offer

Competitive hourly pay
Permanent, casual position offering flexibility
Opportunity to work at a prestigious, exclusive wedding venue with a supportive team
Training and development opportunities to help you grow within the hospitality sector
A friendly and inclusive work atmosphere where your contribution is valued
Employee discounts
Financial Wellness & Flexibility. Access a percentage of your earned wages instantly when you need them plus financial tools & options to save

Parttime

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Senior Angular UI Developer

The Applications Development Senior Programmer Analyst is an intermediate level ...

Location

India , Pune

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

9+ years of relevant experience
Experience in systems analysis and UI programming of software applications
Experience in managing and implementing successful projects
Working knowledge of consulting/project management techniques/methods
Ability to work under pressure and manage deadlines or unexpected changes in expectations or requirements
Bachelor’s degree/University degree or equivalent experience

Job Responsibility

Conduct tasks related to feasibility studies, time and cost estimates, IT planning, risk technology, applications development, model development, and establish and implement new or revised applications systems and programs to meet specific business needs or user areas
Monitor and control all phases of development process and analysis, design, construction, testing, and implementation as well as provide user and operational support on applications to business users
Utilize in-depth specialty knowledge of applications development to analyze complex problems/issues, provide evaluation of business process, system process, and industry standards, and make evaluative judgement
Recommend and develop security measures in post implementation analysis of business usage to ensure successful system design and functionality
Consult with users/clients and other technology groups on issues, recommend advanced programming solutions, and install and assist customer exposure systems
Ensure essential procedures are followed and help define operating standards and processes
Serve as advisor or coach to new or lower level analysts
Has the ability to operate with a limited level of direct supervision
Can exercise independence of judgement and autonomy
Acts as SME to senior stakeholders and /or other team members

Fulltime

Specialist – QA Technical Support NPI

Amgen

Location:
Ireland , Dun Laoghaire

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 12, 2026

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