
Qa Senior Specialist
4 weeks ago
Cpl in partnership with SK pharmteco are hiring a permanent QA Senior Specialist
to join QA Systems team for their site in Swords, Co.
Dublin.
ABOUT US?
SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland.
We are part of SK Inc., a Korean company with revenues of $99 billion in 2023.
Our mission is to 'produce and deliver life-changing therapies that improve patient outcomes and save lives'.
The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years.
With a talented workforce, exceptional technical capabilities and facilities we have made some of the world's most important medicines and continue to do so.
Further information on SK pharmteco can be found at
Current Need:
The Quality Team at the Swords campus are looking for a QA Senior Specialist on a permanent contract.
Position Description:
The QA Senior Specialist is part of the QA Systems team and responsible for the operations of
Site Quality metrics
, leading monthly
Quality Management Review
, back-room lead for all
audits
and inspections, part of the internal Audit team,
Supplier qualification
and
licensing
.
Providing QA systems support to the QA Systems Manager and team members as required.
Advisor on NPI requirements for material qualification from development through clinical to commercial product manufacturing.
This role will report directly to the Quality Systems and Validation Manager.
Main responsibilities (including but not limited to):
·Collate the Site Quality Metrics (weekly/monthly/annually) and monitoring trends with actions.
·Lead the monthly Site Quality Management Review.
·Provide oversight of Supplier qualification.
·Back-room lead for all customer audits and regulatory inspections.
·Part of the internal Audit team on site.
·Main point of contract for all licensing i.e. HPRA ASR, scheduled substances, PMDA etc.
·Assist with Assessment and QA Approval of changes for GMP compliance in accordance with change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes (where required).
·Review and approval of GMP SOPs (where required).
·Ensure that all activities are conducted to meet GMP regulations, site or corporate quality standards and any additional regulatory requirements.
Manage Information
·Metrics and trending to ensure quality and compliance standards are monitored.
Teamwork
·Build effective working relationships to ensure site objectives are delivered on time and to the highest quality.
Manage Finances
·Monitor and control use of finances for licensing.
Safety
·Demonstrate Safety first principles at all times.
Minimum Requirements:
·A Bachelor's or Master's degree in Chemistry or a related scientific field is required, with a minimum of 3 years of experience in the pharmaceutical industry in a similar role.
·The QA Senior Specialist must possess strong initiative and be capable of working both independently and collaboratively across the organization.
·The qualified candidate must demonstrate characteristics aligned with SK pharmteco Values and Behaviours.
Desired/Advantageous
·Previous experience in QA Systems generating Site Quality Metrics.
·Previous experience in Supplier Qualification.
·Experience in Clinical to commercial manufacturing.
·Lean Six Sigma – proven track record improving Systems processes e.g. Metric generation, Supplier Qualification and/or Digitalisation.
·Experience in back room for regulatory inspections or part of Inspection readiness team.
Other Benefits Include:
·Excellent opportunities for career enhancement and personal development.
·Competitive base salary.
·Annual bonus linked to business results.
·A well-established further education program.
·Pension scheme.
·Private healthcare.
#J-18808-Ljbffr
-
Senior (Manual) Engineer- Contract
2 weeks ago
Dublin, Dublin City, Ireland QA Full timeat Archer - The IT Recruitment ConsultancyMid-Senior level Not disclosed Ireland Dublin, County Dublin, Ireland29 days agoJob Title: Senior QA Engineer (Manual Testing) – Contract €400-450/DayLocation: DublinContract Length: 6 months (high potential for extension)Join a Global Leader in Insurance & TechnologyAn exciting opportunity awaits an experienced...
-
QA Senior Specialist Compliance
7 days ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeQA Senior Specialist Compliance - Ireland, Dublin - 6 Months ContractOne of the top 10 best companies to work in Ireland is looking for a QA Senior Specialist Compliance for their large-scale new facility in Dublin. Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion...
-
QA Specialist
3 weeks ago
Dublin, Dublin City, Ireland QCS Staffing Full timeOverviewQA Specialist - Ireland, Dublin – 6 Months Initial ContractAre you a QA Specialist and wanting to join an international team working to improve the future of health care? Our client is a global health care company specialising in delivering lifesaving medicines globally. They have been at the forefront of delivering the health and well-being of...
-
Electrical QA/QC Engineer
3 weeks ago
Dublin, Dublin City, Ireland Specialist Technical Services (STS Group) Full timeOverviewElectrical QA/QC Engineer - Cork/Dublin role at Specialist Technical Services (STS Group). STS Group is seeking an experienced QA/QC Technician or Engineer to join Life Sciences (pharma) projects in Cork or Dublin.Responsibilities Prepare handover testpacks and operation & maintenance manuals. Review and issue final handover documentation to the...
-
QA Distribution Specialist
3 weeks ago
Dublin, Dublin City, Ireland Quanta part of QCS Staffing Full timeOverviewQA Distribution Specialist - Life Science - Contract - DublinAre you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a QA Distribution Specialist to support the QA Distribution Specialist function.Located 15 minutes from Dublin Airport and just a short...
-
Pharmaceutical QA Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000QA Specialist for Pharmaceutical DistributionWe are seeking a highly skilled QA Specialist to support the QA Distribution function. The successful candidate will be responsible for ensuring quality oversight of temperature controlled product activities, assessing shipments, and providing guidance on quality issues related to temperature controlled...
-
Qa Specialist
2 weeks ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeQA Specialist - Dublin, Ireland - 12 Months ContractOne of the top 10 best companies to work in Ireland is looking for QA Specialistfor their large-scale new facility in Dublin.Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project.This fantastic client offers...
-
Qa Specialist Ii
4 weeks ago
Dublin, Dublin City, Ireland Emergent Biosolutions Full timeJoin to apply for theSpecialist II, Quality Assurancerole atEmergent BioSolutionsJoin to apply for theSpecialist II, Quality Assurancerole atEmergent BioSolutionsGet AI-powered advice on this job and more exclusive features.We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a...
-
QA Specialist/RP
3 weeks ago
Dublin, Dublin City, Ireland Thor Companies Full timeQA Specialist & Responsible Person – 12-Month FTC (Hybrid, Ireland)An expanding consultancy within the pharmaceutical and life sciences sector is seeking a QA Specialist & Responsible Person (RP) to join their growing Quality function. This role offers the opportunity to work across a variety of clients while ensuring high standards of compliance and...
-
Senior Qa Engineer
1 week ago
Dublin, Dublin City, Ireland Playrix Full timeSocial network you want to login/join with:Playrixis one of the most successful mobile game development companies.In terms of revenue, we rank among the top 3 in the world and are first among all mobile applications in EMEA.Our games have been installed 2.3 billion times (that's a third of the world's population) and are played by over 30 million people...