Job Title: Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to join our team in Dublin, Ireland. The successful candidate will be responsible for ensuring that the validation activities associated with a syringe filling line for a sterile fill finish facility are in compliance with Good Manufacturing Practices (GMP) and quality requirements.
Responsibilities:
* Develop, execute, review, and approve qualification test documentation (FAT, IVs, FT, SAT, and PQs) associated with a syringe filling line.
* Pre-approve and post-approve validation protocols.
* Contribute to site validation master plans and standard operating procedures (SOPs).
* Assist in resolving exceptions and deviations, as well as conducting root cause analyses.
* Review validation planning documents detailing overall project strategies.
* Review and approve qualification summary reports (QSRs).
* Generate validation summary reports.
* Support the development of user requirement specifications (URS) and quality risk assessments for equipment and automated systems (QRAES).
Requirements:
* 6+ years' experience in engineering or quality assurance.
* Technical qualification at third level or equivalent in engineering.
* Demonstrated expertise in executing validation activities for pharmaceutical/biotechnology projects.
* Experience working with sterile/biotech equipment within the pharmaceutical industry is preferred.
* Knowledge of safety and GMP requirements.
* Strong communication skills.
* Experience using paperless qualification systems is preferred.
* Strong understanding of a risk-based approach to commissioning, qualification, and validation within the biotechnology industry.
* The successful candidate must have an eligible working visa in Ireland or a European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy recruiting professionals for organizations throughout Ireland, UK & Europe.