![West Pharmaceutical Services, Inc](https://media.trabajo.org/img/noimg.jpg)
Senior Quality Specialist
3 weeks ago
Select how often (in days) to receive an alert:
Title: Senior Quality Specialist (Compliance)Requisition ID: 66012
Date: May 31, 2024
Location:
Dublin, Leinster, IE
Department: Quality
Description:
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 departments
Essential 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)
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
#J-18808-Ljbffr-
Senior Manager, IRT Development Supply Quality
3 weeks ago
Dublin, Dublin City, Ireland Quality Analytics Full timeThis is what you will do:The senior manager for IRT Development Supply Quality will provide quality oversight and support to the Product Development - Clinical Supply (PDCS) IRT team in ensuring adherence to quality standards in the setup, operation, and management of Interactive Response Technology (IRT) systems supporting our clinical studies.This role...
-
Senior Quality Specialist
3 weeks ago
Dublin, Dublin City, Ireland West Pharmaceutical Services Full timeJoin our Team at West! At West, we are a team with a mission to enhance patient lives, a legacy that spans over a century. Starting with Herman O. West's breakthrough in supplying penicillin during World War 2, we have been delivering life-saving medicines to millions daily, shaping the healthcare industry. Now, we invite you to be part of this legacy and...
-
Global Head of Quality Operations
3 weeks ago
Dublin, Dublin City, Ireland Quality Analytics Full timeThe Head of Quality Operations is the Quality Business Partner for Alexion Operations, Information Technology (IT) and Product Development & Clinical Supply (PDCS). This role leads the strategy and execution for quality assurance and quality control at Alexion's Manufacturing Facilities and Contract Manufacturing Organizations (CMOs) worldwide. Strategies...
-
Global Head Of Quality Operations
3 weeks ago
Dublin, Dublin City, Ireland Quality Analytics Full timeThe Head of Quality Operations is the Quality Business Partner for Alexion Operations, Information Technology (IT) and Product Development & Clinical Supply (PDCS).This role leads the strategy and execution for quality assurance and quality control at Alexion's Manufacturing Facilities and Contract Manufacturing Organizations (CMOs) worldwide.Strategies will...
-
Quality Specialist
3 weeks ago
Dublin, Dublin City, Ireland Lexconsultancy Full timeThis leading Airline organisation is seeking a Customer Quality & Training Specialist to support the management of the customer quality and training relationship across all teams.The successful candidate will be responsible for developing and implementing the Quality, Communication and Compliance strategy for all customer contact centres, as well as...
-
Project Manager/ Senior Civil Engineer
3 weeks ago
Dublin, Dublin City, Ireland Construction Specialist Recruitment Full timeProject Manager/ Senior Civil Engineer Our client a well-established and progressive Civils and Plant company are seeking a Project manager/Senior Engineer for a range of civil projects in West & Midlands. The projects this company work on include roads windfarms watermain schemes etc.Responsibilities will include:Manage both site staff and subcontractors...
-
Quality Specialist
3 weeks ago
Dublin, Dublin City, Ireland Independent Search Solutions Full timeMy client requires a Quality Specialist to join their Quality Team for a 12 Month Fixed Term Contract. Based in Galway City this leading Life Science & Pharmaceutical Firm has plans to expand its facilities in 2024 and will be looking to take on board an established Quality Specialist who has 3-5 Years' experience already working in a regulated environment...
-
Quality Specialist
1 month ago
Dublin, Dublin City, Ireland Independent Search Solutions Full timeMy client requires a Quality Specialist to join their Quality Team for a 12 Month Fixed Term Contract. Based in Galway City this leading Life Science & Pharmaceutical Firm has plans to expand its facilities in 2024 and will be looking to take on board an established Quality Specialist who has 3-5 Years' experience already working in a regulated environment...
-
Quality Systems Specialist
3 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeOn behalf of my client, a global pharmaceutical company, we are collaborating with them on a new hire for a Quality Systems Specialist.Permanent opportunity with hybrid option.Key responsibilities and reporting to the QA Compliance Manager: ·Support the ongoing management of electronic Quality Management Systems(eQMS) related, but not limited to the...
-
Quality Specialist
3 weeks ago
Dublin, Dublin City, Ireland TES Recruitment Full timeUp to €49,000 a year - Permanent, Full-time Job details Job details Here's how the job details align with yourprofile . Pay Up to €49,000 a year Job type Full-time Permanent Shift and schedule Weekend availability 10 hour shift Night shift Location Dublin, County Dublin Full job descriptionQuality Specialist – Large Food Manufacturing Operation...
-
Quality Specialist, Compliance
3 weeks ago
Dublin, Dublin City, Ireland West Pharmaceutical Services, Inc Full timeSelect how often (in days) to receive an alert: Title: Quality Specialist, Compliance Requisition ID: 63624 Date: Apr 28, 2024 Location: Dublin, Leinster, IE Department: Quality Description: 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...
-
QA Senior Specialist
3 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeCpl in partnership with SK biotek Ireland are looking for a Quality Assurance Senior Specialist on a permanent contract to join the Quality Team at the Swords Campus.SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part...
-
QA Senior Specialist
1 month ago
Dublin, Dublin City, Ireland Cpl Full timeCpl in partnership with SK biotek Ireland are looking for a Quality Assurance Senior Specialist on a permanent contract to join the Quality Team at the Swords Campus.SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part...
-
QA Senior Specialist
3 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeCpl in partnership with SK biotek Ireland are looking for a Quality Assurance Senior Specialist on a permanent contract to join the Quality Team at the Swords Campus.SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part...
-
Quality and Safety Specialist
3 weeks ago
Dublin, Dublin City, Ireland HCI Full timeAt HCI we help providers of health and social care make intelligence driven decisions to attain, manage and improve quality, safety and regulatory compliance. Reporting to the Director of Quality and Safety, the Quality and Safety Specialists role shall include, development, implementation and support of practical quality and safety management systems within...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeSenior Regulatory Affairs SpecialistOur client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the...
-
Senior Specialist, Quality Compliance Global API
2 weeks ago
Dublin, Dublin City, 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 the...
-
Quality Measurement Specialist
3 weeks ago
Dublin, Dublin City, Ireland Meta Full timeYou can create a Career Profile to get job suggestions, prepare for the interview process, and more. Quality Measurement Specialist - Thai Market Quality Measurement Specialist - Thai Market The Global Quality Expert Review Team drives accountability for operational excellence, quality metrics, continuous improvements, and lead the implementation of our...
-
Senior Specialist QA Scientific
3 weeks ago
Dublin, Dublin City, Ireland TEAM HORIZON Full timeTeam Horizon is seeking a Senior Specialist QA Scientific for our client based in Dublin. The Senior Specialist, Quality Systems, to join the Central Quality Systems and Compliance team. This role serves as a pharmaceutical quality subject matter expert and supports global colleagues across Operations, Commercial, Device, IT and Quality partners. The...
-
Quality Assurance Specialist
3 weeks ago
Dublin, Dublin City, Ireland Xcenda, LLC Full timeQuality Assurance Specialist page is loaded Quality Assurance Specialist Apply locations Cork, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R247699 Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being...