Senior Quality Specialist
5 months ago
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Summary:
The primary responsibilities of the Senior Quality Specialist involve Systems over-sight customer focus within our all Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis. For coordinating the necessary activities for ensuring the timely closure of internal/external quality issues / projects and to coordinate / drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Ensuring site compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. Reports directly to the Quality Compliance Manager.
Requirements:
Must have a third level qualification in Engineering/Quality/Science. Level 8 qualification in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience. Must have 5+ years’ work experience in Medical Device or Pharmaceutical Manufacturing Environment. A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4/ EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage. Knowledge of and experience in setting up and maintaining an effective QMS. Accredited lead auditor against recognised quality standards in support of internal and supplier audits Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971. Experience of hosting regulatory audits from either the European or US authorities Must have excellent communication and written skills Must be able to work in a fast paced environment. Must be able to travel as required by the position. Must be able to organize and prioritize tasks; must be detail orientated and self-motivated. An ability to collaborate across functional lines and work effectively in a team environment Must be able to work independently on own projects while working concurrently with all departmentsEssential Duties and Responsibilities:
Understand and ensure compliance with internal procedures and external global regulatory requirements. Lead investigations related to Quality System related issues to ensure a thorough root cause, containment / corrective and preventive action is implemented. Support trend analysis and issuance of key reports to relevant departments. Support responses to Competent Authority queries. Support risk management, risk analysis and hazard analysis associated with complaint/post-market information. Actively participate as Lead Auditor in Internal & External Audit Schedule. Support of third party audits, control room set-up and management of general audit readiness throughout the business. Post Audit follow-up and reporting both internally & externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactory. DHR review of Medical Device to be conducted within the QMS. Responsible for the scheduling, data collection and co-presenting Management Review. Support and drive the improvement and culture for data integrity. Coach and drive a culture of compliance and continuous improvement. Develop processes and systems in line with best industry practice. Coordinate the monthly Quality Systems KPI reporting activity both internally and to corporate level. Support regulatory submissions as required. Interface with other departments on a regular basis to ensure adherence to West QMS, drive quality improvements and compile/relay trends and occurrences throughout the year. Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct. Compliance to all site Environmental, Health and Safety requirements, training and regulations. Compliance to all local site company policies, procedures and corporate policies. Perform additional duties at the request of the direct supervisor.Delegation of Duties:
When absent from the site duties and responsibilities will be delegated to the following designates
Job Title: Quality Specialist Complaints and/or Quality Systems Co-ordinator
(for Routine Quality System responsibilities)
Job Title: Quality Compliance Manager & Quality Manager
(for all responsibilities outside of routine Quality System responsibilities)
-
Senior Quality Auditor Specialist
3 weeks ago
Dublin, Ireland Recruitment by Aphex Group Full timePurpose The Senior Quality Audit Specialist will be responsible for supporting the audit and inspection function. They are to manage the end to end process for audits and inspections, including preparation, conduct and supporting the response commitment process to closure. Responsibilities Key QMS experience is essential, ranging from exposure to CAPAs,...
-
Senior Quality Specialist
4 months ago
Dublin, Ireland Endo Operations Limited Full timeDescription The Senior Quality Specialist, Quality Operations leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. Provides quality guidance on product transfers and validations and will ensure that all activities related...
-
Quality Specialist
2 weeks ago
Dublin, Ireland ESB Full timePosition Description Are you looking for a new challenge? A Brighter, zero carbon future awaits! Join the Capability Assurance (CAM) team in Transmission and Distribution Engineering (TDE) in ESB Engineering and Major Projects. We are responsible for the Quality Management processes, safety coordination, and developing the Engineering capability within the...
-
Senior Engineer
3 months ago
Dublin, Ireland Construction Specialist Recruitment Full timeSenior Engineer Dublin CSR group is currently recruiting for a Site Based Senior Engineer. Our client is one of Irelands leading Main Contractors. The company itself has been around for nearly 70 years delivering quality projects throughout Ireland and in just about every sector of the industry. This will be for a large Residential Project They have multiple...
-
Quality Specialist
2 months ago
Dublin, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Quality Specialist
2 months ago
Dublin, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
-
Senior Estimator
4 months ago
Dublin, Ireland Construction Specialist Recruitment Full timeSenior Estimator - Main Contractor An Senior Estimator is required on behalf of a leading main contractor based in Dublin to prepare accurate and competitive cost estimates for a wide variety of building projects throughout Leinster. You will analyse the risks and opportunities inherent in the proposals, provide on-going support to the project teams and...
-
Senior Quantity Surveyor
4 months ago
Dublin, Ireland Construction Specialist Recruitment Full timeThe CSR Group is currently looking to recruit a Senior Quantity Surveyor on behalf of a residential developer in Dublin. With sites across Leinster, the company are growing their commercial team with the addition of a Senior Quantity Surveyor to take a key role overseeing a number of sites. Wit a strong managerial and commercial background, the successful...
-
Senior Specialist, Quality Compliance Global API
5 months ago
Dublin, Ireland Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Senior IT Support Specialist
2 weeks ago
Dublin, Ireland Reperio Human Capital (Ireland) Ltd Full timeSenior IT Support Specialist Contract | €250-€280/day | Dublin A client of mine is seeking an experienced Senior IT Support Specialist to join their team in Dublin. This role involves delivering Level 2 and 3 support, troubleshooting technical issues, and managing network and cloud-based services in an onsite environment. You'll be responsible for...
-
Quality Systems Specialist
5 months ago
Dublin, Ireland TEAM HORIZON Remote Work Freelance Full timeDescription Team Horizon is seeking a Quality Systems Specialist for our client, a leading Biotechnology company in Dublin. This is a 12-month initial contract. Why you should apply: Exciting opportunity to provide QMS support for combination products for the product lifecycle and the associated Quality System and engage with all stakeholders...
-
Senior IT Support Specialist
2 weeks ago
Dublin, Ireland Reperio Human Capital Full timeSenior IT Support SpecialistContract | €250-€280/day | DublinA client of mine is seeking an experienced Senior IT Support Specialist to join their team in Dublin. This role involves delivering Level 2 and 3 support, troubleshooting technical issues, and managing network and cloud-based services in an onsite environment. You'll be responsible for...
-
Senior Health
2 weeks ago
Dublin, Ireland Construction Specialist Recruitment Full timeJob role: Senior Health & Safety officer - Dublin Our client one of Irelands leading building contractors is looking to recruit a H&S Professional to work under the H&S Lead across multiple sites in Dublin. Your role will be reporting directly to the H&S Lead while completing everyday Duties on site. They promote Health & Safety as being a main priority...
-
Management Sys Specialist/ Quality Analyst
1 week ago
Dublin, Ireland Brightwater Full timeManagement Systems Specialist/ Quality Analyst 6 Months Temporary Contract About the Company My client is a well-known public sector organisation, currently seeking multiple candidates forManagement Systems Specialist / Quality Analyst roles. About the Position This will initially be a 6 Month temporary contract with high likelihood of extension or...
-
Claims Quality Review Specialist
3 months ago
Dublin, Ireland Berkshire Hathaway Specialty Insurance Full timeJob Opportunity: Berkshire Hathaway Specialty Insurance (BHSI) is seeking a Claims Quality Review Specialist to join the Global Claims Quality Assurance. This role can be based in any one of our main European locations, including London, Cologne, Paris, Madrid or Dublin. This position entails regular communication and collaboration with multiple...
-
Senior QA Specialist
3 weeks ago
Dublin, Ireland PE Global Full timeThe role: PE Global is currently recruiting for a Senior QA Specialist on behalf of a leading pharmaceutical company based in Dublin North. This is an initial 12 month contract role. Description: Key QMS experience is essential, ranging from exposure to CAPAs, de Support key stakeholders during the preparation and management of audits/inspections. Support...
-
Specialist QA
3 months ago
Dublin, Ireland Amgen Full timeThe Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. QA specialists will be required to understand and grasp a broad range of quality related competencies. The QA Specialist will report to the PQA Packaging & Complaints Senior Manager and will be required to be a Subject Matter Expert in their assigned area of...
-
Project Manager
1 week ago
Dublin, Ireland Construction Specialist Recruitment Full timeJob Opportunity: Project Manager Location: South Dublin, Ireland Sector: Residential Development Project: Large-Scale Residential Development Employment Type: Full-Time, Fixed-Term Contract (Project Duration) Salary: Competitive, Commensurate with Experience Start Date: Immediate About the Role: We are seeking a highly skilled Project Manager to oversee the...
-
Senior Quality Assurance Associate
4 months ago
Dublin, Ireland TEAM HORIZON Remote Work Freelance Full timeDescription Team Horizon is seeking a Senior Quality Assurance Associate for our Client, who are a leading biotechnology company based in Dublin. Why you should apply: This is an excellent opportunity to join a forward thinking company and work in a state of the art facility. What you will be doing: Testing of primary and secondary...
