Validation Specialist
4 days ago
Direct message the job poster from Life Science Recruitment
Contract Life Science Recruiter ~ CQV ~ Validation ~ QA ~ QPs12 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
- Contract
- Manufacturing, Quality Assurance, and Science
- Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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