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Validation Engineer

I am working with a leading biopharmaceutical company who are currently looking for a QA Validation Consultant for a 9 month contract.

The client is a multibillion speciality bio-pharmaceutical company with over 150 years' experience improving outcomes for patients with severe and critical needs.

They have an excellent reputation on the market and they are known for mastering and managing complexity in making high quality products that provide value for patients.

They have a growing portfolio and invest in areas that include autoimmune and rare diseases in areas like neurology, rheumatology and neonatal respiratory care

products. They have an excellent contract role open for a QA Validation consultant

Role: QA Validation Consultant

Length: 9 months Daily rate contract

Location: Dublin West

You will be the Quality Validation Consultant that will work closely between the Quality and Validation team.

Day-day:

  • Represent QA on Site, QA Department, and other Department (non-QA) projects to ensure compliance to GMP.
  • Reviewing and approving GMP documentation e.g., SOPs, reports, methods, specifications, validation protocols, quality contracts etc.
  • Review and approval of change controls.
  • Review & Approval of validation/CSV documentation to ensure that site validation requirements are met.
  • Ensuring Data Integrity per 21 CFR Part 11 / Annex 11 Requirements
  • Process validations against corporate SOP/FDA/EMEA requirements.
  • Development of project plans for Validation/Qualification projects.
  • Participates in internal and external audits and inspections where required

Your Skill-set:

  • Bachelor's Degree in engineering or scientific discipline preferred plus 5+ years' experience working as a QA Validation consultant or QA/ Validation Engineer in a cGMP manufacturing environment
  • Experience in pharmaceutical manufacturing.
  • Good interpersonal skills are required, as is the ability to communicate well, both verbally and written. Must be able to function effectively in a teamwork environment
  • Experience working with automated systems or CSV is a big plus
  • Experience working in biotech industry is desirable but not necessary

This is an excellent opportunity to work in one of the leading Biotech companies that will give you exposure to both Quality and Validation teams

For immediate consideration please apply with an up to date CV. Not sure yet? No CV ready? Give me a call for more information

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales