129 Jobs in Monkstown

Are you an experienced Class 1 Driver looking for a new adventure? With continued growth, we’re on the lookout for Class 1 Drivers to join our dynamic team working in partnership with TK Maxx at our NEW Site in Dublin.

You’ll be working on a full-time, permanent  basis, 42.5 hours per week, on an ‘any 5 from 7’  shift pattern with start times between 01:30 - 09:00 (Plus 1 night shift in approx every 8 weeks is required)

Pay, benefits and more:

• An hourly rate of up to €20.44 + shift allowance for night shifts and Sundays.
• Weekly paid
• Daily Meal allowance
• 20 days annual leave (exclusive of bank holidays)
• A company sponsored pension scheme
• A 24/7 online GP service, life assurance and fully comprehensive employee assistance programme
• Admission to GXO University, our online learning platform enabling you to achieve your career aspirations!

What you’ll do on a typical day:

• 2 to 3 deliveries to TK Maxx stores
• Complete all allocated paperwork correctly when needed
• Provide excellent customer service at every site you visit

• Always drive economically to improve driving fuel efficiency and conserve

What you need to succeed at GXO:

• A full EU driving licence with category C+E entitlement
• A valid Driver Qualification Card (Driver CPC)
• Be in possession of a valid Digital Tachograph Card
• No more than 6 current penalty points
• No DR, DG, DD, BA, CD, AC, LC or TT99 endorsements with a conviction date within the previous 5 years

We engineer faster, smarter, leaner supply chains.

GXO is a leading provider of cutting-edge supply chain solutions to the most successful companies in the world. We help our customers manage their goods most efficiently using our technology and services. Our greatest strength is our global team – energetic, innovative people of all experience levels and talents who make GXO a great place to work.
 
GXO is an equal opportunity employer. We celebrate, support and thrive on diversity and are committed to creating an inclusive environment for all employees.  We believe that diversity and inclusion in our business is critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. We are an Armed Forces friendly organisation and Disability Confident Leader as part of the Disability Confident Scheme (GIS) and actively welcome applications from people with disabilities.
 
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All employees may be required to perform duties outside of their normal responsibilities from time to time, as needed. #appcastuk

Are you an experienced Class 1 Driver looking for a new adventure? With continued growth, we’re on the lookout for Class 1 Drivers to join our dynamic team working in partnership with TK Maxx at our NEW Site in Dublin.

You’ll be working on a full-time, permanent  basis, 42.5 hours per week, on an ‘any 5 from 7’  shift pattern with start times between 01:30 - 09:00 (Plus 1 night shift in approx every 8 weeks is required)

Pay, benefits and more:

• An hourly rate of up to €20.44 + shift allowance for night shifts and Sundays.
• Weekly paid
• Daily Meal allowance
• 20 days annual leave (exclusive of bank holidays)
• A company sponsored pension scheme
• A 24/7 online GP service, life assurance and fully comprehensive employee assistance programme
• Admission to GXO University, our online learning platform enabling you to achieve your career aspirations!

What you’ll do on a typical day:

• 2 to 3 deliveries to TK Maxx stores
• Complete all allocated paperwork correctly when needed
• Provide excellent customer service at every site you visit

• Always drive economically to improve driving fuel efficiency and conserve

What you need to succeed at GXO:

• A full EU driving licence with category C+E entitlement
• A valid Driver Qualification Card (Driver CPC)
• Be in possession of a valid Digital Tachograph Card
• No more than 6 current penalty points
• No DR, DG, DD, BA, CD, AC, LC or TT99 endorsements with a conviction date within the previous 5 years

We engineer faster, smarter, leaner supply chains.

GXO is a leading provider of cutting-edge supply chain solutions to the most successful companies in the world. We help our customers manage their goods most efficiently using our technology and services. Our greatest strength is our global team – energetic, innovative people of all experience levels and talents who make GXO a great place to work.
 
GXO is an equal opportunity employer. We celebrate, support and thrive on diversity and are committed to creating an inclusive environment for all employees.  We believe that diversity and inclusion in our business is critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. We are an Armed Forces friendly organisation and Disability Confident Leader as part of the Disability Confident Scheme (GIS) and actively welcome applications from people with disabilities.
 
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All employees may be required to perform duties outside of their normal responsibilities from time to time, as needed. #appcastuk

Are you an experienced Class 1 Driver looking for a new adventure? With continued growth, we’re on the lookout for Class 1 Drivers to join our dynamic team working in partnership with TK Maxx at our NEW Site in Dublin.

You’ll be working on a full-time, permanent  basis, 42.5 hours per week, on an ‘any 5 from 7’  shift pattern with start times between 01:30 - 09:00 (Plus 1 night shift in approx every 8 weeks is required)

Pay, benefits and more:

• An hourly rate of up to €20.44 + shift allowance for night shifts and Sundays.
• Weekly paid
• Daily Meal allowance
• 20 days annual leave (exclusive of bank holidays)
• A company sponsored pension scheme
• A 24/7 online GP service, life assurance and fully comprehensive employee assistance programme
• Admission to GXO University, our online learning platform enabling you to achieve your career aspirations!

What you’ll do on a typical day:

• 2 to 3 deliveries to TK Maxx stores
• Complete all allocated paperwork correctly when needed
• Provide excellent customer service at every site you visit

• Always drive economically to improve driving fuel efficiency and conserve

What you need to succeed at GXO:

• A full EU driving licence with category C+E entitlement
• A valid Driver Qualification Card (Driver CPC)
• Be in possession of a valid Digital Tachograph Card
• No more than 6 current penalty points
• No DR, DG, DD, BA, CD, AC, LC or TT99 endorsements with a conviction date within the previous 5 years

We engineer faster, smarter, leaner supply chains.

GXO is a leading provider of cutting-edge supply chain solutions to the most successful companies in the world. We help our customers manage their goods most efficiently using our technology and services. Our greatest strength is our global team – energetic, innovative people of all experience levels and talents who make GXO a great place to work.
 
GXO is an equal opportunity employer. We celebrate, support and thrive on diversity and are committed to creating an inclusive environment for all employees.  We believe that diversity and inclusion in our business is critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. We are an Armed Forces friendly organisation and Disability Confident Leader as part of the Disability Confident Scheme (GIS) and actively welcome applications from people with disabilities.
 
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All employees may be required to perform duties outside of their normal responsibilities from time to time, as needed. #appcastuk

At U.S. Bank, we're on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions, enabling the communities we support to grow and succeed in the right ways, all more confidently and more often-that's what we call the courage to thrive. We believe it takes all of us to bring our shared ambition to life, and each person is unique in their potential. A career with U.S. Bank gives you a wide, ever-growing range of opportunities to discover what makes you thrive. Try new things, learn new skills and discover what you excel at-all from Day One.
As a wholly owned subsidiary of U.S. Bank, Elavon is committed to building the platforms and ecosystems that help over 1.5 million customers around the world to achieve their financial goals-no matter what they need. From transaction processing to customer service, to driving innovation and launching new products, we're building a range of tailored payment solutions powered by the latest technology. As part of our team, you can explore what motivates and energizes your career goals: partnering with our customers, our communities, and each other.
**Job Description**
The **Customer Remediation** department plays a vital role in upholding the bank's commitment to fairness, transparency, and trust. By swiftly addressing errors, service failures, or regulatory breaches, the team ensures that affected customers are treated with integrity and restored to the position they should have been in. Beyond resolving individual issues,
Customer Remediation drives systemic improvements by identifying root causes and influencing long-term change across the organisation. Our work not only protects the bank's reputation and regulatory standing but also reinforces customer confidence-demonstrating that the bank is accountable, responsive, and genuinely **committed to doing the right thing** .
As an **Errors Co-Ordinator** within the **EU** **Customer Remediation** team, you will play a critical role in identifying, tracking, and resolving customer-impacting errors. You will ensure that all remediation activities are accurately documented, root causes are analysed, and corrective actions are implemented efficiently and in compliance with regulatory standards. Supporting programmes across 12 different countries and 9 languages we have developed a diverse, inclusive, and collaborative working environment.
**Key Responsibilities:**
+ **Error Identification & Logging:**
+ Log and categorise errors in the central tracking system with appropriate detail and urgency.
+ **Root Cause Analysis:**
+ Collaborate with cross-functional teams to investigate the origin of errors, particularly whether they are isolated or systemic in nature.
+ Investigate and document the root cause analysis (RCA) of all errors, considering whether appropriate procedures and controls are implemented to avoid recurrence and/or recommend preventative measures.
+ **Remediation Coordination:**
+ Coordinate the end-to-end remediation process, ensuring timely and accurate resolution of customer issues.
+ Track progress of remediation actions and escalate delays or risks to management.
+ **Stakeholder Communication:**
+ Act as a liaison between internal teams to ensure alignment and timely progress on remediation activities.
+ Provide regular updates and reports to senior stakeholders on error trends and resolution status.
+ **Compliance & Documentation:**
+ Ensure all remediation activities are documented in line with procedural, regulatory and internal audit requirements.
+ Support audit and compliance reviews by providing accurate and timely information.
+ **Continuous Improvement:**
+ Identify opportunities to improve error detection and remediation processes.
+ Contribute to the development of training materials and process enhancements.
**Key Skills & Qualifications:**
+ Demonstrated ability to **lead complex remediation** **efforts** with minimal supervision.
+ **Strong stakeholder management and communication skills** , including experience presenting to senior leadership.
+ **Advanced prioritisation and time management skills** , with a proven track record of managing competing demands across multiple jurisdictions.
+ **Experience mentoring junior colleagues** and contributing to team capability-building.
+ High proficiency in Microsoft Office applications (Excel, Word, Outlook, PowerPoint).
+ Deep understanding of customer remediation, quality assurance, or operational risk.
+ Working knowledge of regulatory frameworks (e.g. CPC, Consumer Duty, FCA, GDPR).
+ Ability to influence cross-functional teams and drive systemic change through RCA insights.
**Why Join Us?**
+ Be part of a purpose-driven team focused on delivering fair outcomes for customers.
+ Work in a collaborative environment with opportunities for growth and development.
+ Help shape and improve processes that make a real difference.
**Additional information:**
+ The role offers a hybrid / flexible schedule, which means there's an in-office expectation of 3 or more days per week and the flexibility to work outside the office location for the other days.
+ Location - Arklow or Cherrywood
_This position is not eligible for visa sponsorship._
If there's anything we can do to accommodate a disability during any portion of the application or hiring process, please refer to our disability accommodations for applicants ( .
**Benefits** :
We offer an exciting, fast-paced and diverse working environment with employees of many different nationalities. We provide benefits to help you protect your health and financial security; and give you peace of mind. We also invest in your career growth with development resources that give you the opportunity to stretch and shine.
**Posting may be closed earlier due to high volume of applicants.**

**Introduction**
Elevate Your Career with IBM Ireland - Join Us as a Software Developer!
Are You Ready to Shape the Future of AI and Cloud Technology?
At IBM Ireland, we're not just developing software; we're revolutionizing the way businesses operate. As a part of our elite teams, you'll build the cutting-edge AI-powered, cloud-native and AI solutions. You will reimagine how current and future industries will evolve. Here, your ideas matter, and your work will shape the future!
Why IBM Ireland?
Innovate with Impact: Be at the forefront of technological innovation, developing backend services and APIs that power our world-class AI-infused management features.
Collaborate & Thrive: Work alongside industry-leading Architects, AI Experts, Product Managers, DevOps Engineers, and Test Automation Engineers in a dynamic, multi-disciplinary environment that fosters creativity and teamwork.
Endless Growth Opportunities: With our global reach and commitment to innovation, IBM Ireland is the perfect place to advance your career and explore new possibilities. Our doors are always open for those eager to learn and grow!
**Your role and responsibilities**
What We're Looking For:
* Tech Savvy: You have a strong passion for modern software development using languages such as Java, Python, Javascript, C/C++, Go etc and a keen interest and/or understanding of web applications, GenerativeAI and cloud technologies. Demonstrates a firm grasp of software development methodologies.
* Growth Minded: You are at your best when working with the best. You love mentoring and being mentored and always willing to learn new skills/technologies for you and your colleagues.
* Self-Starter: You're a proactive problem-solver who takes initiative and thrives in a fast-paced, dynamic setting.
What Are the Opportunities in IBM Ireland:
As a Developer at IBM Ireland, there are opportunities to work across the following roles/areas:
* Backend Development Design and build robust microservices and APIs using Java, driving the next generation of our hybrid cloud management products.
* Frontend Development Create stunning experiences for users of our software, solving design and user experienced by leveraging your creative problem-solving skills.
* Fuel the Future of Software Technology: Work at the heart of our technology ecosystem, ensuring that our development and operational processes are seamless, efficient and scalable through pipeline automation. If you are passionate about making processes faster and more efficient, this is the area for you.
* Be a Guardian of Quality: If you have keen eye for detail and a passion for quality, a love for uncovering hidden issues, we have roles that will meet your curiosity and detective skills.
Join Us at IBM Ireland and Be Part of Something Extraordinary!
Are you a growth-minded individual ready to make a real impact? Do you thrive in an environment where learning and collaboration are key? If so, we want to hear from you!
Apply Now and Start Your Journey with IBM Ireland - Where Innovation Meets Opportunity!
**Required technical and professional expertise**
* Experience with algorithms, data structures, GenerativeAI/LLMs.
* Familiarity with test automation frameworks.
* Container technologies (Docker, Kubernetes), and microservices.
* Cloud technologies (IBM Cloud, AWS, Azure etc).
IBM is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, caste, genetics, pregnancy, disability, neurodivergence, age, veteran status, or other characteristics. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

**Introduction**
At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most challenging problems? If so, lets talk.
**Your role and responsibilities**
We are looking for Software Engineers who are self-starters, quick learners, and who enjoy working in a challenging, fast paced environment. Members of our team work with the world's leading companies in industries including banking, commerce, insurance, social media, transportation and governments as they enable their mission critical business applications via the web. Responsibilities include providing remote technical support assistance to our clients using Problem Determination (PD) and Problem Source Identification (PSI) skills.
In addition to determining recommendations for problem resolution, our engineers
communicate action plans to our clients to ensure that the client is satisfied with steps
towards resolution or the problem's root cause. Our engineers continually flex their
programming and technology skills through driving problem resolution using improvements to existing and/or new technical Support tools and procedures which can often include examining source code, providing feedback to development for product improvement, creating test cases, creating tools or providing debug modules to our clients.
This position is specifically for Technical Support Engineer candidates who will be part of a worldwide team responsible for diagnosing and troubleshooting software problems within Automation and App Modernization spanning multiple operating systems, virtual, and cloud.
**Required technical and professional expertise**
* Knowledge of Java
* Experience in Distributed/UNIX/Linux operating systems
* English language skills
* Communication and client focused skills - be able to understand customer problems and articulate complex issues
* Ability to troubleshoot and identify the root cause of issues
IBM is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, caste, genetics, pregnancy, disability, neurodivergence, age, veteran status, or other characteristics. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

At U.S. Bank, we're on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions, enabling the communities we support to grow and succeed in the right ways, all more confidently and more often-that's what we call the courage to thrive. We believe it takes all of us to bring our shared ambition to life, and each person is unique in their potential. A career with U.S. Bank gives you a wide, ever-growing range of opportunities to discover what makes you thrive. Try new things, learn new skills and discover what you excel at-all from Day One.
As a wholly owned subsidiary of U.S. Bank, Elavon is committed to building the platforms and ecosystems that help over 1.5 million customers around the world to achieve their financial goals-no matter what they need. From transaction processing to customer service, to driving innovation and launching new products, we're building a range of tailored payment solutions powered by the latest technology. As part of our team, you can explore what motivates and energizes your career goals: partnering with our customers, our communities, and each other.
**Job Description**
Java J2EE Developer
Be part of something big, where integrity matters and success inspires, where great people collaborate, innovate and give back, where you feel included, valued and proud. At U.S. Bank we're looking for people who want more than just a job - they want to make a difference in the communities where they live and work.
U.S. Bank is seeking an Agile Application Developer with design and development experience to contribute toward the success of our technology initiatives. In this role you will be part of the team established to configure and develop complex application systems using existing and emerging technology platforms in an agile lifecycle. You will consult with business users on requirements gathering, and be deeply involved in system design, configuration, and implementation. You'll be working closely with the Delivery Manager, IT development, and Architecture groups while collaborating with several lines of business.
**As an Agile Application Developer you will:**
+ analyse business needs and deliver Java EE multi-tier solutions
+ be an enthusiastic team player acting as an ambassador for product delivery, self-starting and proactive
+ be an analytical thinker and problem solver who provides follow-through on problems
+ have excellent English language skills, verbal and written, and an ability to collaborate with other teams
+ have the ability to communicate systems solutions or issues using appropriate language, both written and oral to business and technical stakeholders
+ have a proven ability to reverse engineer and refactor legacy applications
+ have a good grasp of industry standards, best practices and design patterns
+ be able to work under pressure and react to ever-changing user requirements
+ be willing to adapt to significant changes in either technology or environment
+ ensure that all programs are fully tested and documented and that customer and Elavon information is kept secure in line with the acceptable use policy and other published security policies, standards and best practice;
**Basic Qualifications**
+ Bachelor's degree, or equivalent work experience
+ A **minimum of 5 years Java and Java EE application development** experience
+ Eclipse or equivalent IDE
+ SOAP and RESTful web-service implementation experience
+ Hands on experience with Struts or equivalent framework (e.g. Spring MVC/JSF), Hibernate or equivalent ORM (Object Relational Mapping) Tools, Spring Framework
+ Hands on experience with AJAX, JSP, JSP Tag libraries
**Preferred Skills/Experience**
+ Camel, AMQ, Kafka
+ JBoss , Websphere
+ Junit, Test Mocking Frameworks, CSS, JQuery
+ DB2 Database or equivalent experience
+ Modern development tool chain utilities such as Confluence, Git / Bitbucket, Jenkins, Maven, Artifactory / Nexus
The role offers a hybrid / flexible schedule, which means there's an in-office expectation of 3 or more days per week and the flexibility to work outside the office location for the other days.
_This position is not eligible for visa sponsorship._
If there's anything we can do to accommodate a disability during any portion of the application or hiring process, please refer to our disability accommodations for applicants ( .
**Benefits** :
We offer an exciting, fast-paced and diverse working environment with employees of many different nationalities. We provide benefits to help you protect your health and financial security; and give you peace of mind. We also invest in your career growth with development resources that give you the opportunity to stretch and shine.
**Posting may be closed earlier due to high volume of applicants.**

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
PCI JOB DESCRIPTION Job Title: JD-066
Qualified Person (Hybrid - 3rd Party Products) Department:
Quality Division / Section:
Clinical Services Accountable to:
Associate Director of Quality Accountable for: (People Manager)
Yes - includes managerial support to QA specialists
Responsibilities
Overall Quality Responsibilities
The Qualified Person is responsible for certifying investigational medicinal products in accordance with requirements of Investigational Medicinal Product Dossier (IMPD), Product specification File (PSF).
-The compliance of all batches to EU Directives, Annex 16 and Detailed Commission Guidelines where applicable for Investigational Medicinal Products (IMPs).
-Provide the Quality management team direct support and guidance in all quality matters to ensure that Quality operations meet the required site safety, quality, and cGMP requirements.
-Participate in cross functional teams to provide consultative support on quality related issues.
-Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs).
-During review, the QP ensures that all regulatory requirements are met regarding importation, testing and the release of clinical product to third party sites.
-Completion of QP Declarations to declare product manufactured in accordance with both trial-specific processes as well as EU GMP standards.
-Complete the QP review/disposition of Drug Substance/ Drug Product and Finished Pack product of Biologics, Steriles, ATMP's, across a range of dosage forms e.g Parenteral, Topical, Inhalational, Rectal, Opthalmic.
Quality Operations
-Review batch documentation to ensure that the entire process has been performed in accordance with relevant product specification file (PSF), and cGMP/cGCP, and that it meets customer and agency audit standards.
-Review of clinical Batch records, including control reports, in-process test reports and release reports demonstrating compliance with the product specification file, the order, protocol, and randomization code
-Disposition (back to customer QPs or clinical trial site) and certify completed batches efficiently.
-Achieve "right first time" objectives, tracking quality and efficiency standards.
-By direct observation and intervention, monitor the application of quality standards to enable quality processes, compliant documentation, timely corrective action and continuous improvement.
Quality Systems
-Provide support with investigations and resolution of discrepancies within deviations. Participating in cross functional teams as Quality/Qualified Person representative
-Lead or provide CAPA recommendations.
-Support to change control impact assessments and completion.
-Communicating with contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organizations, and
-Completion of third-party contractor and supplier quality agreements and supply chain documents.
-Provide audit support as required for client Health Authority Inspections, internal auditing, supplier audits. Ensuring any observations are adequately and promptly addressed.
-Provide experienced support to Customer complaints and deviations and join cross functional resolution initiative.
Quality Projects and Continuous Quality Improvement
-Provide support to direct QA reports, in development, progress and feedback.
-Give quality direction and guidance for projects related to processes, product and compliance
-Compile new and update existing technical agreements.
-Support the Quality team in implementation of new product introductions.
-Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice
-Develop and sustain an environment of continuous improvement through active implementation of process excellence and lean six-sigma methodologies.
-Actively promote best practice in quality methods and drive continuous improvement initiatives to improve quality, cost and cycle times.
-Develop training programs and support in training rollout.
General
-Collaboration across the organisation and act as SME/team representation on required meetings.
-Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice. Research, analyse and extrapolate critical regulatory information
-Knowledge of 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use and the Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
-Knowledge on quality systems regulations, QA principles and industry best practices and standards and utilize in day-to-day activities.
Secondary Responsibilities
-Provide supervisory support to QA specialists and complete review and feedback on batch record review. Support in mentorship capacity.
-Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
REQUIREMENTS
-Bachelor's degree in science, engineering, technology or a related discipline.
-Qualified Person status or eligibility for QP status. Clinical Experience desirable but not essential.
-At least 3-5 years' experience in a quality management role in the Pharma industry.
-Sound industry knowledge of the requirements of EU GMP, steriles experience is desirable.
-Extensive quality systems and quality operations experience.
-Strong organisational / time management skills. Effective interpersonal communications, leadership and excellent decision making skills.
-Experience of working at management level within a similar environment.
-High motivation, flexibility and the ability to work under pressure and on own initiative.
All employees are required to satisfactorily perform the essential duties and responsibilities of their position. The essential duties and responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills required.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled