Validation Specialist

4 days ago


South Dublin, Ireland Life Science Recruitment Full time

Direct message the job poster from Life Science Recruitment

Contract Life Science Recruiter ~ CQV ~ Validation ~ QA ~ QPs

12 month contract

Hybrid role - South Dublin

QA Validation Specialist

AMC34126

I am currently looking for a QA Specialist with experience in Validation including validation of lab equipment and CSV.

The ideal candidate will have 7+ years experience in pharmaceutical manufacturing including at least 8 months lab experience as well as 3-4 years experience in validation roles. They will be familiar with QRS, risk assessments and the validation life cycle.

Key Responsibilities

  • Provide overall quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Automation & Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
  • Quality review and approval of Validation documentation and SOPs to support site validation activities:
  • Review of DS & QRAES documents
  • Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
  • Review of executed validation documents and reports
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
  • Perform all activities in compliance with company safety standards and SOPs.

Preferred Qualifications

  • University degree. Science or Engineering related discipline preferred.
  • Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Information Systems).
  • Understanding of principles of Validation and New Product Introduction.
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.

If you are interested in this role apply today or get in touch with Angela McCauley for more information.

Seniority level
  • Associate
Employment type
  • Contract
Job function
  • Manufacturing, Quality Assurance, and Science
Industries
  • Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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