QA Validation Lead

2 days ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

QA Validation Lead at SK pharmteco

Location: Swords, Co Dublin

Contract: 12 months

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 world's most important medicines and continue to do so. Further information on SK pharmteco can be found at www.skpharmteco.com.

Current Need

We are looking for a QA Validation Lead who will be responsible for:

  1. Qualification of Computer system qualification.
  2. Familiarity with ALCOA+ Data Integrity and Compliance Assurance.
  3. Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
  4. Laboratory equipment validation and NPI's.
  5. Review and approval of the GMP design aspects of major capital projects including Software upgrading and Qualifying/validation Recipes.
  6. Ensure all quality systems are implemented/executed in compliance with ICH Q7, EudraLex, 21 CFR and site Quality standards.
  7. Knowledge of GMP guide, Annex 11, QMS, LIMS, and EBR.
  8. Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines, and trends. Review master and complete qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
  9. Knowledge of Risk-Based Validation for IQ/OQ/PQ.
  10. Participate in other projects as directed by the Quality Systems & Validation Manager.
  11. High level interaction with the various functions on site: Manufacturing, QC, Utilities, and Engineering.
Minimum Requirements
  1. Min of BSc/BEng in Computer application/Engineering or a science-related discipline with at least 4-5 years pharmaceutical experience ideally in a CSV role.
  2. Must have experience leading projects with a small team (1-2 people).
  3. Preferably with experience in change control/documentation management, good manufacturing practices.
  4. Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT.
  5. Some experience in Operational Excellence or project management would be desirable.
  6. Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
  7. The QA Validation lead must possess strong initiative and be capable of working both independently and collaboratively across the organisation.
  8. Strong interpersonal, communication, and presentation skills are required for this position as well as good time management, multi-tasking, and organisational skills.
#J-18808-Ljbffr

  • QA Validation Lead

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    QA Validation Lead at SK pharmtecoLocation: Swords, Co DublinContract: 12 monthsABOUT USSK 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...

  • QA Validation Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are Seeking a QA Validation Specialist to join the team at their state of the art Dublin, Grange Castle Plant for an 11 month fixed term contract with Hybrid working model.Role:To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including...

  • QA Validation Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Hobson Prior Full time

    Hobson Prior is collaborating with a Biotech company who are in search of a Specialist in QA Validation. The chosen individual will offer supervision for the production and distribution of Gene Therapy medicinal products. They will be instrumental in guaranteeing that processes and equipment meet validation and qualification standards as per relevant...

  • QA Validation Lead(North Dublin)

    5 days ago

    Dublin, Dublin City, Ireland DPS Group Global Full time

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from DPS Group Global.Responsibilities:Qualification of Computer system qualification.The QA Validation lead must possess strong initiative and be capable of working both independently and collaboratively across the organisation.Strong interpersonal, communication and...

  • Qa Systems And Validation Specialist

    2 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    QA Systems and Validation Specialist (12 month Contract) Location: Swords Campus,ABOUT US 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 of the wider SK Inc. with revenues of $95 billion in 2020.Our mission is to...

  • QA Systems and Validation Specialist

    2 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    QA Systems and Validation Specialist(12 month Contract)Location: Swords CampusABOUT USSK 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 of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to...

  • Validation Associate

    5 days ago

    Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full time

    Role OverviewWe are seeking a highly skilled Validation Associate to join our team. As a key member of our technology strategy & transformation practice, you will play a crucial role in ensuring the quality and compliance of our clients' IT/OT systems.About UsOleson is a specialist provider of consultancy and implementation services for IT infrastructure and...

  • QA Lead

    4 weeks ago

    Dublin, Dublin City, Ireland Reperio Human Capital Full time

    QA Lead 99837 Desired skills: Automation, QA Lead, Test QA Lead, Dublin, €75,000 - €80,000 Responsibilities: Leadership: Lead and mentor a team of QA engineers, providing guidance, support, and technical expertise to ensure the team's success. Quality Assurance Strategy: Develop and implement comprehensive quality assurance...

  • Validation Engineer

    6 days ago

    Dublin, Dublin City, Ireland Validation Associates Llc Full time

    The ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business.We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing.Our role is to be a companion on the road for technology teams to be able to use as a tool at times...

  • Validation Engineer

    4 weeks ago

    Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full time

    The ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. Our role is to be a companion on the road for technology teams to be able to use as a tool at times...

  • GxP Validation Specialist

    6 days ago

    Dublin, Dublin City, Ireland Validation Associates Llc Full time

    The role of a Validation Engineer is pivotal in ensuring the seamless integration and operation of technology systems within GxP environments.At Validation Associates LLC, we are seeking a talented professional to join our team as a Validation Engineer.This position offers an exceptional opportunity to work with our blue-chip multinational clients within the...

  • QA Systems and Validation Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland DPS Group Global Full time

    Position Description:The QA Systems and Validation Specialist will be responsible for:Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.Review and approve the GMP design aspects of major capital projects including new facility...

  • QA Systems and Validation Specialist New

    3 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    QA Systems and Validation Specialist(12 month Contract)Location: Swords Campus,ABOUT US?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 of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to...

  • QA Systems and Validation Specialist New

    2 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    QA Systems and Validation Specialist(12 month Contract)Location: Swords CampusABOUT US?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 of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to...

  • QA Systems and Validation Specialist New

    1 week ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with SK biotek are looking for QA Systems and Validation Specialist on a 12 month Contract to join the team in the Swords Campus.ABOUT US?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 of the...

  • QA Systems and Validation Specialist New

    13 hours ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with SK pharmteco are looking for QA Systems and Validation Specialist on a 12 month Contract to join the team in the Swords Campus.ABOUT US?SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, USA, France and Ireland. We are part of the wider SK Inc. with...

  • Validation Lead Expert

    16 hours ago

    Dublin, Dublin City, Ireland CPL Full time

    Job Description: QA Validation LeadThe successful candidate will be responsible for:Qualifying computer systems and equipment in accordance with GMP guidelines.Evaluating changes for GMP compliance, including assessment of facilities, utilities, lab, and manufacturing equipment control system changes.Leading laboratory equipment validation and new product...

  • Qa Lead Specialist

    2 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl, in partnership with SK biotek, 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 with...

  • QA Lead

    2 weeks ago

    Dublin, Dublin City, Ireland Reperio Human Capital Full time

    Location: Athlone, Westmeath, Republic of IrelandType: PermanentStart: ASAPDesired skills:Java, Cucumber, JmeterWe are seeking a highly skilled and experienced QA Lead to join our client in County Westmeath. The ideal candidate will have a strong background in backend automation using Google Cloud Platform (GCP), Java, and Cucumber, as well as hands-on...

  • QA Lead Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl, in partnership with SK biotek, 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 with...