Quality Specialist

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

On behalf of our client, we are currently recruiting for a Quality Specialist /Responsible Person for a 12 month fixed term contract. There is potential for permanency. Flexibility to work remotely/hybrid with regular onsite attendance at client locations. Applications for reduced hours may also be considered.

Key Accountabilities/Responsibilities:


•Support the Quality team with the maintenance of the Company's QMS;


•Ensuring compliance to ISO 9001 and GMP requirements and internal procedures;


•Managing the internal QMS such as raising non-conformances, change controls, CAPAs, quality complaints etc. as required


•Maintenance of the supplier management system, including completion of supplier evaluations, assessment and repeat evaluations according to internal procedures;


•Ensuring compliance to Internal Audit schedules, executing internal audits;


•Ensuring continual improvement, maintenance of internal KPIs


•Liaising with fellow team members and ensuring awareness to changes to QMS as appropriate.

Specific to role of Responsible Person for nominated clients:


•Ensure compliance with the requirements of EU GDP guidelines and other relevant guidelines including HPRA local guidelines


•Experience working under MHRA GDP requirements would be an advantage


•Ensure the safety, quality and traceability of products are maintained through the entire supply chain


•Ensure that the conditions of the Wholesale Distribution Authorisation are met and that all medicinal products wholesaled, are received, stored, transported, and delivered under strict GDP conditions


•Ensure that all bona fides of suppliers /customers/service providers are conducted and maintained in a timely manner


•Ensure self-inspections and audits are carried out as per written audit schedule


•Act as the main point of contact and be legally responsible to the HPRA and advise HPRA of any changes in a timely manner for those WDA's where you are the nominated RP


•Lead regular management review meetings with Senior management teams


•Coaching/Mentoring Quality professionals/Deputy RPs


•Ensure patient safety and product safety at all times

Requirements

·This role requires a B.Sc. in a Life Science subject and 5+ years of Quality and GDP expertise, including previous experience named as an RP on a WDA in Ireland.

·Minimum of 5 years experience in Quality and GDP


•A minimum of one year's experience named as an RP on a wholesale distribution authorization in Ireland


•Thorough working knowledge of EU GDP requirements


•Ability to represent clients across different levels of the organization, including dealing with competent authorities


•Experience hosting client and competent authority is essential


•Experience and comprehensive knowledge of ISO 9001 standard, GMP and GDP guidelines


•Experience performing audits would be an advantage


•Strong interpersonal and communication skills with proven ability to influence people both internally and externally to achieve objectives.


•Ability to project manage and multi-task workload


•Excellent attention to detail, with client satisfaction an integral part of your work ethic


•Maintain client confidentiality and observe discretion at all times


•Strong work ethic


•Experience with EQMS implementation is desirable but not a requirement


•Ability to work with different clients and different product portfolios

For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

#LI-LD1

#J-18808-Ljbffr

  • Junior Project Specalist

    6 days ago

    Dublin, Dublin City, Ireland Quality Matters Full time

    Junior Project Specalist Quality Matters is seeking a Junior Project Specialist to support research, facilitation, evaluation, and advocacy for impactful non-profit projects. About Quality MattersQuality Matters is a Dublin-based charity and social enterprise. We work nationally to support improvements in health and social care services. Our mission is to...

  • Quality Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Besins Healthcare Full time

    Join to apply for the Quality Specialist role at Besins HealthcareJoin to apply for the Quality Specialist role at Besins HealthcareGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Besins HealthcareRecruitment Officer at Besins HealthcarePurpose of the job:The main purpose of this position is management of the...

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeQuality Full time

    Quality Assurance SpecialistWe are seeking a Quality Assurance Specialist to join our team in an international environment. As a Quality Assurance Specialist, you will play a key role in ensuring the quality of our products and services.The ideal candidate will have several years of experience within a quality role in an Aseptic manufacturing environment....

  • Quality Assurance Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Ampstek Full time

    Direct message the job poster from AmpstekThis is a hands-on QA specialist position in a fast-growing global business and development teamCreate and execute test plans for Releases and SprintsSuccessfully interpret and clarify business requirements, and translates the business requirements into specific case designs for very large complex solutions and...

  • Quality Assurance Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Ampstek Full time

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from AmpstekThis is a Sr. QA position for the Issuer application team to perform tests on innovative solutions that not only meet functionality requirements but also meet performance, scalability and reliability requirements while adhering to development and delivery...

  • Quality Assurance Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland eTeam Full time

    Join to apply for the Quality Assurance Specialist role at eTeamJoin to apply for the Quality Assurance Specialist role at eTeamDirect message the job poster from eTeam• Contract type: 6-month fixed-term contract (Maternity Cover)• Client: A global healthcare company committed to advancing medical innovation and improving patient outcomes through...

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Atrium (EMEA) Full time

    Direct message the job poster from Atrium (EMEA)Quality Assurance Specialist – Medical DevicesLocation: Dublin, Ireland (Hybrid – 2 to 3 days on site)Contract: Long-term projectThis isn't just another QA role - it's your chance to be part of something meaningful and exciting, where your voice will be heard, your ideas will help shape the way things are...

  • Quality Systems Specialist

    6 days ago

    Dublin, Dublin City, Ireland JobContax Full time

     Quality Systems Specialist - Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location:  HybridPay: €45 - €57 per hourExperience: 7+ years Visa: EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun...

  • Quality Systems Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland JobContax Full time

    Social network you want to login/join with:Quality Systems Specialist - Dun Laoghaire, DublinEmployment Type: ContractWork Location:HybridExperience: 7+ yearsVisa:EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.The plant is...

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeTestManager Full time €60,000 - €80,000

    Job Opportunity: Quality Assurance SpecialistThe role of a Quality Assurance Specialist involves overseeing the entire testing lifecycle and maintaining quality control processes.Main Responsibilities:Engage with stakeholders to ensure the highest quality of software products.Develop comprehensive test strategies to meet testing objectives.Create test cases...