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Senior Quality Systems Manager

2 weeks ago

Athlone, County Westmeath, Ireland beBeeQuality Full time €70,000 - €90,000
Quality Assurance Specialist Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products and services, maintaining regulatory compliance, and collaborating with internal stakeholders.

Key Responsibilities:
  • Develop and implement quality systems to ensure compliance with regulatory guidelines and company policies.
  • Represent Quality in manufacturing operations, resolving issues and providing guidance as needed.
  • Provide quality input and oversight of the manufacturing facility, including data integrity.
  • Generate QMS Standard Operating Procedures (SOPs) to reflect processes that promote compliance and efficient operations.
  • Review and approve procedures, documents, and records to ensure compliance with facility requirements.
  • Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA.
  • Support the site change control system, evaluating proposed change controls and making informed assessments of quality impact.
  • Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
Required Skills and Qualifications:
  • Bachelor's degree in a science discipline.
  • Minimum 3-7 years' experience working in finished product pharmaceutical/biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
  • Excellent knowledge of quality systems, FDA and EU regulations, cGMPs, and ICH guidelines.
  • Demonstrated capability in establishing collaborative working relationships at all levels.
  • Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems.
Benefits:

This role offers excellent opportunities for professional growth and development, with the chance to work with a talented team in a dynamic environment.

Others:

We offer a competitive compensation package and a range of benefits, including training and development opportunities.