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QA Assistant

Tuesday, may 05, 2020
Description

Why work for this company?

Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.

Company Profile

  • 65+ years of experience in animal health.
  • Nearly $6 billion annual revenues.
  • 25 manufacturing sites around the world.
  • 10,000 employees worldwide of which 1,100 employees are committed to R&D.

Role Purpose:

The QA Assistant will take an active role in documentation control activities, archiving and tracking of all non-conformance and quality events or issues.

Reporting Structure:

Reporting to the Quality Operations Manager.

Duties & Responsibilities:

  • Issuance and control of BMRs, batch documentation and labels. Issuance of controlled documentation for all departments.
  • Filing and archival of documentation and support setup of Archival process.
  • Electronic Quality Management System (Veeva Vault) administrator.
  • Assist with the training of all personnel in the use of the EQMS & Learning management system (LMS).
  • Control and review of site training files.
  • Partake and contribute to internal audits and monthly Audit readiness inspections.
  • Buffer and media manufacturing record review and SAP release.
  • Partake in the review of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of cGMP and the validated process. Participate in QA review of batch processing.
  • QA review of QC data.
  • Compilation of data for regulatory submissions.
  • Assist QA documentation control centre, resolve documentation issues that may arise and help produce relevant metrics to monitor efficiency.
  • Electronic Tracking System (ETS) QA support.
  • Co-ordinate change management and CAPA systems.
  • Provide support to Equipment qualification and validation activities.
  • Manage specific projects that may arise in a timely and efficient manner.

Education:

  • Third level degree in a life Science discipline.
  • 6-12-month experience working in a GMP environment preferable.
  • Strong analytical and technical skills.
  • Excellent interpersonal and communication skills, meticulous eye for detail.
  • Self- motivation.
  • Computer literate.
  • Strong time management awareness and the ability to drive projects forward.

Due to a high volume of applications only those being progressed to the next stage will be contacted

Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003


Job Reference:QA50
Position Type:Temporary
Sector:Biotechnology & Pharmaceutical, pharmaceutical
Working Hours:Full-Time
Location:Offaly, Offaly, Ireland
Salary:Dependent on Experience
Contact:Randstad Financial & Professional, Randstad Financial Services, London, United Kingdom
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