Pharmaceutical Systems Expert

4 days ago


Nenagh, County Tipperary, Ireland Next Generation Full time
Job Overview

We are seeking a highly skilled Pharmaceutical Systems Expert to join our quality assurance team. As a key member of our team, you will play a critical role in ensuring compliance, process validation, and continuous improvement to maintain the highest standards of pharmaceutical production.

Key Responsibilities:
  • Ensure Compliance & Quality Excellence: Oversee key quality systems, ensuring compliance with industry regulations and internal policies.
  • Act as the subject matter expert (SME) for validation processes, change control, and quality agreements.
  • Support internal audits, regulatory inspections, and quality council meetings.
  • Lead & Support Validation and Change Control: Participate in validation committees for process, cleaning, water, and equipment.
  • Approve validation documents, ensuring compliance and ongoing process improvements.
  • Provide quality oversight for change control processes, ensuring robust assessments and approvals.
  • Support Laboratory & Supplier Quality: Provide quality oversight for laboratory systems, including stability reports and incident investigations.
  • Act as a key liaison for microbiology-related quality concerns.
  • Review and approve supplier change evaluations and technical agreements.


Requirements:
  • Education:
  • Strong knowledge of pharmaceutical quality systems, GMP standards, and validation principles.
  • Technical Skills:
  • Familiarity with laboratory testing, plant operations, and quality documentation.
  • Soft Skills:
  • Excellent communication, problem-solving, and stakeholder management skills.


About Us
We are a leading organization in the pharmaceutical industry, committed to delivering high-quality products and services. Our rigorous quality assurance processes ensure the highest standards of pharmaceutical production.

What We Offer
We provide a dynamic work environment that fosters growth, collaboration, and innovation. Our team members enjoy a range of benefits, including opportunities for professional development and a competitive compensation package.

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