QA Specialist

1 month ago


Sligo, Ireland Phibro Animal Health Corporation Full time

Position Details

The QA Validation Specialist will be responsible for delivery of Quality Assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. The role will also include the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.

This role will be a key member of the Quality Assurance team, providing hands-on technical support and oversight for validation activities at the manufacturing facility. This role is essential in ensuring that processes and equipment are validated and qualified according to industry regulations while guiding the implementation of the Site Validation Master Plan. This key role is an individual contributor role whereby the individual must be a self-starter with professional and academic experience in QA and Validation activities. This key role must ensure effective interaction with other departments such as Quality Control, Manufacturing, Engineering and Technical Services.

RESPONSIBILITIES

Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk. Review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing. Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements. QMS areas of responsibility include Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials. Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility. Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements. Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines. Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA Act as the QA lead in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others. Actively contribute to continuous improvement activities. Other duties as assigned.

EDUCATION /EXPERIENCE

Third level qualification in relevant science and/or engineering discipline 5 years minimum experience working in a in a GMP Quality environment providing QA technical support and oversight to validation and qualification activities  Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations

Core Competences

Strong understanding of GMP compliance and quality standards In-depth knowledge of quality management system (QMS) procedures and technical documentation Excellent analytical, problem-solving, and decision-making skills Excellent attention to detail and significant document review experience essential Excellent technical writing skills including deviation reports and SOPs Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail
  • QA Specialist

    1 month ago


    Sligo, Ireland FRS Recruitment Full time

    Quality Assurance Specialist (Validation) SligoPharmaceutical/Biotechnology/Manufacturing**Job Summary:** We're seeking a dynamic **QA Specialist (Validation)** to ensure our products meet GMP and regulatory standards. You'll play a key role in reviewing validation documents and overseeing facility, equipment, and utility qualifications. This hands-on role...


  • Sligo, Ireland Headcount Solutions Limited Full time

    QA Manufacturing Compliance Specialist (Biologics)Rotating Day and Evening Shift.We are actively seeking to recruit a QA Compliance Specialist to become a key member of the Quality Team within a West of Ireland based Pharma manufacturer. This is an on site role with a rotating day and evening shift pattern.Responsibilities• Ensure that all products leaving...

  • QA Specialist

    1 month ago


    Sligo, Ireland Phibro Animal Health Corporation Full time

    Position Details POSITION SUMMARY The QA Specialist will be responsible for delivery of Quality Assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. The role will involve providing direct quality support to Operations at the facility.  The role will include the review and approval of batch...


  • Sligo, Co. Sligo, Ireland Gertek Project Management Full time

    GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...

  • Operations Specialist

    1 month ago


    Sligo, Co. Sligo, Ireland Cpl Resources Full time

    Operations Specialist - Quality Assurance Biotechnology Manufacturing Sligo Permanent I am looking to speak with candidates that have 3 years in QA function coupled with circa 5 years industry for the newly created role of QA Operations. You will haveknowledge of batch related documentation and activities related to on-going manufacturing including the...


  • Sligo, Ireland FRS Recruitment Full time

    Quality Assurance Specialist (Operations) SligoPerm role - HybridWe are seeking a detail-oriented Quality Assurance Specialist for our Operations function to ensure products are manufactured in compliance with GMP and regulatory standards. You will provide quality support to operations, focusing on reviewing batch documentation, managing investigations,...


  • Sligo, Ireland Abbott Full time

    About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full...

  • Micro Lab Manager

    3 weeks ago


    Sligo, Co. Sligo, Ireland Next Generation Recruitment Full time

    Job Title: Micro Lab Manager Location - Sligo A rapidly expanding biopharmaceutical manufacturer are at a pivotal time in our growth. They are in the late stages of developing and commercialising a new portfolio of innovative biopharmaceutical products. As they continue to expand, they are looking for a dedicated Microbiology Manager to lead their Micro...