Quality Assurance Specialist

3 weeks ago

Sligo, Sligo, Ireland QCS Staffing Full time
Overview

Quality Assurance Specialist - Ireland, Sligo - 12 Month Contract
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Quality Assurance Specialist to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people's lives. They have 50,000 employees around the world and are continuing to grow.

Responsibilities
  • Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.
  • Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products.
  • The Quality Assurance Specialist / Qualified Person (QP) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.
  • To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.
Desirable Experience
  • Third level qualification in a science discipline with extensive experience in the pharmaceutical industry.
  • MSc in Industrial Pharmaceutical Science or similar course recognised by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
  • Requires extensive industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
  • Strong experience gained within an aseptic processing environment, ideally gained within a quality function.

If this role is of interest, please apply now

Seniority level
  • Mid-Senior level
Employment type
  • Contract
Job function
  • Quality Assurance

#J-18808-Ljbffr

  • Quality Assurance Specialist

    2 weeks ago

    Sligo, Sligo, Ireland beBeeCompliance Full time €45,000 - €75,000

    Job Title: Quality Assurance Specialist">The Quality Assurance Specialist is responsible for coordinating, implementing and maintaining the site validation program to ensure compliance with external regulatory requirements and industry best practices.This role involves oversight of validation activities for equipment, utilities, processes and software, as...

  • Quality Assurance Specialist

    2 weeks ago

    Sligo, Sligo, Ireland beBeeQuality Full time €40,000 - €60,000

    Quality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to fill a key role on a 12-month contract basis. This position is designed to provide maternity cover for a vital team member.Key ResponsibilitiesAuthoring and processing Non-Conformances (NCs) and Corrective Action Preventative Actions (CAPAs) in a highly regulated...

  • Quality Assurance Specialist

    2 weeks ago

    Sligo, Sligo, Ireland beBeeValidation Full time €48,360 - €56,320

    Job Title: Quality Assurance Specialist"],

  • Quality Assurance Specialist

    2 weeks ago

    Sligo, Sligo, Ireland beBeeValidation Full time €45,000 - €60,000

    Job Title: Quality Assurance SpecialistThe role of a Quality Assurance Specialist is crucial in ensuring that all site equipment, utilities, processes, and software are validated and maintained to meet external regulatory, quality, and compliance requirements.Key Responsibilities:Develop and implement the site validation master plan, oversee the execution of...

  • Quality Assurance Specialist

    1 week ago

    Sligo, Sligo, Ireland beBeeQualityAssurance Full time €60,000 - €80,000

    \Job Title: Quality Assurance Specialist\To coordinate the development and maintenance of site validation program and ensure quality and compliance requirements are met. Coordination implementation and active participation in the site Validation Program and general Quality Assurance activities.\Responsibilities\\Coordination direction and active...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Sligo, Sligo, Ireland beBeeQuality Full time €60,000 - €80,000

    Job Title: Senior Quality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to join our team.Key Responsibilities:Support engineering projects and daily operations with a focus on compliance, validation, and quality risk management.Evaluate systems and processes to ensure they meet EU GMP standards and are inspection-ready.Key...

  • Quality Assurance Role

    2 weeks ago

    Sligo, Sligo, Ireland beBeeQuality Full time €55,000 - €80,000

    Quality Assurance SpecialistLocated on the west coast of Ireland, this pharmaceutical facility is seeking a Quality Assurance Specialist to join their team. This role involves ensuring full compliance with quality system requirements and auditing processes.Key Responsibilities Include:Coordinate assigned elements of the quality system to ensure full...

  • Quality Assurance Professional

    1 week ago

    Sligo, Sligo, Ireland beBeeCompliance Full time €55,000 - €65,000

    Job OverviewThe Quality Assurance Specialist/QP plays a crucial role in ensuring compliance with EU Guidelines for Good Manufacturing Practice, certification by a Qualified Person, and batch release.This position is responsible for the disposition of bulk product manufactured at site.Key Responsibilities:Ensure compliance with EU Guidelines for Good...

  • Laboratory Quality Assurance Specialist

    2 weeks ago

    Sligo, Sligo, Ireland beBeeQuality Full time €44,411 - €56,123

    About the RoleThis laboratory quality assurance specialist position requires a highly motivated and detail-oriented individual to maintain laboratory documentation and computerized systems data integrity requirements.The ideal candidate will understand regulations and business processes to maintain laboratory data integrity, perform housekeeping duties in...

  • Ensuring Excellence in Quality Assurance

    2 weeks ago

    Sligo, Sligo, Ireland beBeeInnovation Full time €45,000 - €55,000

    Quality Assurance SpecialistWe are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring that all engineering activities are carried out in compliance with GMP and site quality engineering standards.The role involves providing oversight for equipment qualification, utility validation, facility...