Senior QA Associate

3 weeks ago

Dublin, Dublin City, Ireland PE Global (UK) Full time

Description:

PE Global is currently recruiting for a Senior QA Associate on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

This is a shift position.

The shift patterns are as follows: 07:00 to 19:00, and 19:00 to 07:00. (4 on, 4 off).

Overview:

  • The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team.
  • As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.
  • This is a 24/7 shift role required to support manufacturing operations.

Role Responsibilities:

  • Ensure adherence to safety standards and SOPs in all activities.
  • Review and approve production batch records and associated documentation for Qualified Person disposition activities.
  • Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
  • Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
  • Offer Quality Assurance support for on-the-floor investigations and deviations.
  • Review and approve deviations for closure, ensuring compliance with appropriate documentation.
  • Participate in customer complaint investigations.
  • Conduct routine Quality Assurance walks on the production floor.
  • Review and issue logbooks, ensuring compliance with procedures.
  • Provide training and guidance to staff for effective performance.
  • Review and approve cGMP records, ensuring compliance with appropriate documentation.
  • Support continuous improvement and Operational Excellence initiatives.

Skills required:

  • Minimum Qualification: Science Degree /Engineering degree
  • Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Excellent written and verbal communication skills.
  • Experience working with dynamic cross-functional teams and proven abilities in decision making.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Demonstrated ability in problem solving particularly in supporting non-conformance/deviation investigations.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

#J-18808-Ljbffr

  • Senior Qa Associate

    3 weeks ago

    Dublin, Dublin City, Ireland Pe Global (Uk) Full time

    :PE Global is currently recruiting for a Senior QA Associate on behalf of a leading biotech company based in Dublin South.This is an initial 12-month contract role.This is a shift position.The shift patterns are as follows: 07:00 to 19:00, and 19:00 to 07:00.(4 on, 4 off).Overview:The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager...

  • QA Sr Associate

    4 weeks ago

    Dublin, Dublin City, Ireland Team Horizon Full time

    Team Horizon is seeking a CW QA Sr Associate (Senior) for our client based in Dublin. The Sr. Associate in Quality Assurance (QA) will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.The Sr. Associate in Quality Assurance will...

  • Senior (Manual) Engineer- Contract

    2 weeks ago

    Dublin, Dublin City, Ireland Qa Full time

    at 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 Associate

    2 weeks ago

    Dublin, Dublin City, Ireland TEAM HORIZON Full time

    Social network you want to login/join with:Team Horizon is seeking a QA Senior Associate (Senior) on an initial 12-month contract for our Dublin based client who are a global leader in the field of biotechnology.Why you should apply:This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably...

  • Operations Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland QA Full time

    Mid-Senior level Not discloses Ireland Dublin, County Dublin, Ireland20 hours agoThe role:PE Global is currently recruiting for a QA Operations Specialist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract and a 4 cycle shift position.• Shift will be 4 days on, 4 days off with 12 Hour Shifts (7am -...

  • Qa Senior Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    QA Senior SpecialistPermanentLocation:Swords, Co. Dublin, IrelandAbout the company?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...

  • Qa Snr Associate

    4 weeks ago

    Dublin, Dublin City, Ireland Life Science Consultants Full time

    LSC have a great opportunity for a QA Snr Associate to join a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.If you have 4+ years of experience in construction management/engineering within the pharmaceutical or biotechnology industry and are ready for your...

  • Qa Senior Specialist Compliance

    24 hours ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA 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...

  • DPEM Person in Plant-Drug product external manufacturing

    3 weeks ago

    Dublin, Dublin City, Ireland QA Full time

    DPEM QA Person in Plant-Drug product external manufacturing (Dublin, Ireland)at Eli Lilly and CompanyMid-Senior level Not discloses Ireland Limerick, County Limerick, Ireland20 hours agoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our...

  • QA Assurance Lead

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €79,100 - €89,900

    Senior QA Specialist Job OverviewWe are seeking a highly skilled and experienced Senior QA Specialist to join our team at SK pharmteco's Swords campus.Job Responsibilities:The ideal candidate will have a strong background in quality assurance, excellent communication skills and the ability to work independently.Responsibilities include ensuring customer...