Urgent QA Lead Specialist
3 days ago
QA Lead Specialist 12 months contract position Location: Swords Campus 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 Korea 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 worlds most important medicines and continue to do so. Further information on SK pharmteco can be Current Need: The Quality Team at SK pharmteco Ireland here at the Swords Campus are looking for a QA Lead Specialist on a 12 month contract basis. Position Description: The QA Lead Specialist is part of the QA team reporting and responsible for the QA elements of operational readiness to integrate a new plant/projects on site. Experience in similar large CAPEX projects within QA on Operational readiness is required with expert knowledge of PQS, QMS, Validation and Systems regulations. Previous experience from clinical through to commercial manufacturing experience is desirable. Providing QA support to the QA Manager as required. This role will report directly to the QA Manager. Main responsibilities (including but not limited to): *Work with Key stakeholders to develop/execute a readiness plan to ensure all GMP aspects of the new Facility/Project are aligned, functional, and ready to support Business requirements. *Ensure integration of key GMP requirements including procedural controls, facility controls and training requirements to support on time transition from project phase to operational use in line with Project schedule and Site QMS. *Support Validation documentation as required. *Manage risk/identify potential gaps and implement strategies to mitigate them as relevant *Ensure that all activities are conducted to meet GMP regulations, site or corporate quality standards and any additional regulatory requirements. Manage Information *Use of site documentation management system, deviation/CAPA/CC system and training systems. Teamwork *Build effective working relationships to ensure site objectives are delivered on time in full and to the highest quality. 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 5 years of experience in the pharmaceutical industry in a similar role. The QA Lead 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 biotek Ireland Values and Behaviors. Desired/Advantageous Experience/skills in: *Previous experience in QA CAPEX projects *QA Operational readiness *Validation requirements and handovers *Systems experience *Experience in Clinical to commercial manufacturing *Lean Six Sigma proven track record improving QA Operations/Systems/Validation processes *Experience in regulatory inspections or part of Inspection readiness team
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QA Lead Specialist
3 weeks ago
Dublin, Ireland Cpl Resources - TEG Full timeQA Lead Specialist 12 months contract position Location: Swords Campus 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 Korea company with revenues of $99 billion in 2023. Our mission is to produce and deliver...
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QA Lead Specialist
3 days ago
Dublin, Ireland Cpl Full timeCpl, in partnership with SK pharmteco, is looking to hire a QA Lead Specialist on a 12 month contract, to join the team in the Swords Campus, North 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 Korea company...
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QA Lead Specialist New
3 weeks ago
Dublin, Ireland CPL Full timeQA Lead Specialist 12 months contract position Location: Swords Campus 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 Korea company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver...
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QA Lead Specialist New
3 weeks ago
Dublin, Ireland CPL Full timeQA Lead Specialist 12 months contract position Location: Swords Campus 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 Korea company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver...
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▷ [Urgent] QA CQV Specialist
1 week ago
Dublin, Ireland Tandem Project Management Ltd. Full timeSummary Our client, based in Louth, has an opportunity for a QA CQV Specialist to join their team. This role is responsible for providing quality oversight of all validation and qualification activities, ensuring compliance with current regulatory requirements, cGMP, and company SOPs. The position covers validation activities for facilities, utilities,...
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QA Distribution Specialist
1 week ago
Dublin, Ireland Quanta part of QCS Staffing Full timeQA Distribution Specialist - Life Science - Contract - Dublin Are 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...
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Technical QA Specialist
3 days ago
Dublin, Ireland JobContax Full timeTechnical QA Specialist, Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location: Hybrid Onsite requirement is 3 days per weekPay: €50 - €57 per hourExperience: 7+ yearsVisa: EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic...
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QA CQV Specialist
1 week ago
Dublin, Ireland PSC Biotech® Corporation Full timeOverview Join to apply for the QA CQV Specialist role at PSC Biotech Corporation . 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...
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Qa Specialist
4 weeks ago
Dublin, 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...
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Specialist Qa Ts
4 weeks ago
Dublin, Ireland Amgen Inc. (Ir) Full timeSpecialist QA TS page is loaded## Specialist QA TSremote type: Flex Commuter / Hybridlocations: Ireland - Dun Laoghairetime type: Full timeposted on: Posted Todayjob requisition id: R-******## **Career Category**Quality## ## **Job Description****Senior Quality Assurance Professional – QA Technical Support**Amgen is committed to unlocking the potential of...
