1 день назад
Investigation Lead (Biopharma)
31 200 - 41 600€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Investigation Lead (Biopharma): Leading technical and product quality investigations for pre-filled syringe operations with an accent on root-cause analysis, CAPA implementation, and cGMP compliance. Focus on facilitating cross-functional investigations, trending quality data, closing deviations and commitments, and preventing repeat occurrences in a sterile manufacturing environment.
Location: Waterford, Ireland; onsite, day shift
Salary: €31,200–€41,600 per year
Company
is an R&D-driven biopharmaceutical company developing medicines and vaccines.
What you will do
- Lead technical and product quality investigations for pre-filled syringe operations, identifying root causes and implementing corrective and preventative actions.
- Facilitate cross-functional investigations on shift using Gemba tools and provide subject matter expertise for the Investigation System.
- Collect, trend, and analyze quality data to identify process and system improvement opportunities.
- Drive closure of deviations, commitments, CAPAs, and customer complaint actions within required timeframes.
- Coach shift teams on compliance, continuous improvement, and right-first-time documentation.
- Support quality systems operations and internal, corporate, supplier, customer, and regulatory audits.
Requirements
- Knowledge of cGMP and quality systems in a regulated environment.
- Experience with system investigations and remediation processes.
- Sterile manufacturing experience is beneficial.
- Strong accuracy, attention to detail, interpersonal, and problem-solving skills.
- Ability to work onsite in Waterford, Ireland, on a day shift.
- Availability for a 23-month fixed-term contract.
Culture & Benefits
- Opportunity to support life-changing treatments and medicines.
- Career development through stretch roles, cross-functional moves, and development opportunities.
- Inclusive, high-performing teams focused on quality, safety, and continuous improvement.
- Eligibility to participate in company employee benefit programs.
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