13 дней назад
Sr. Associate IQA (Pharmaceutical Quality Assurance)
55 284 - 74 796€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Associate IQA (Pharmaceutical Quality Assurance): Inspecting and releasing primary and secondary packaging components for aseptic product manufacturing with an accent on incoming inspection, cGMP documentation, and quality investigations. Focus on sampling materials under Grade C conditions, managing CAPA and non-conformance activities, supporting audits, and driving continuous improvement.
Location: Dublin, Ireland; onsite 16/5 shift
Salary: €55,284–€74,796 per year
Company
is a biotechnology company focused on developing and manufacturing medicines.
What you will do
- Inspect and test primary and secondary packaging components used in aseptic product manufacturing.
- Sample excipients and drug substances under Grade C conditions.
- Review and approve component-testing documentation and cGMP records for disposition activities.
- Compile, review, and approve minor non-conformances and CAPAs, ensuring root causes and implementation plans are addressed.
- Participate in supplier complaint investigations, audits, training, SOP management, and continuous improvement initiatives.
Requirements
- Must pass the required eye tests for visual inspection.
- University degree, preferably in engineering or a science-related discipline.
- At least four years of relevant experience in the pharmaceutical or biotechnology industry, or an equivalent combination of education and experience.
- Strong written and verbal communication, organizational, decision-making, and problem-solving skills.
- Experience managing root-cause analysis, non-conformance, and deviation investigations.
- Experience with aseptic operations, protein formulation, and vial or syringe filling is preferred.
Culture & Benefits
- Work as part of a cross-functional Quality Assurance team reporting to a QA Manager.
- Participate in site-wide continuous improvement and Operational Excellence initiatives.
- Support staff through training and advice on component testing.
- Perform all activities in accordance with safety standards, policies, and SOPs.
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