Senior Quality Assurance Expert

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000
Job Title: Quality Assurance Specialist Job Description:We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our organization and support key quality activities within the Quality Assurance Department.This role requires a solid understanding of quality assurance systems, current Good Manufacturing Practices (cGMPs), and standard QA procedures. The ideal candidate is proactive, able to exercise sound judgment within established protocols and guidelines, and possesses excellent communication skills. Key Responsibilities:- Participate in inter-departmental and cross-functional teams.- Author site contributions to Annual Product Quality Reviews and coordinate with global teams.- Conduct counterfeit assessments related to product complaints.- Investigate customer complaints in a timely and thorough manner.- Collect and report on quality metrics.- Contribute to the authoring, reviewing, and approval of Standard Operating Procedures (SOPs) and other controlled documents.- Conduct QA walkthroughs to ensure site compliance with GMP requirements.- Work on routine assignments, recognizing deviations from standard practices. Qualifications and Experience:- Minimum of 2 years of relevant experience in a GMP-regulated environment.- Bachelor's degree in a scientific or related field.- Previous experience in the pharmaceutical industry, ideally within a QA function, is preferred.- Strong working knowledge of cGMPs and quality systems (FDA / EMA standards).- Familiarity with OPEX Lean tools and root cause analysis methodologies.- Demonstrated skill in audits, investigations, and technical report writing.- Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint). Preferred Personal Attributes:- Positive and proactive mindset.- Resilient and adaptable in dynamic environments.- Ability to engage with multiple stakeholders to meet objectives.- Curious, with a strong desire to learn and improve.- Demonstrates operational excellence and a systematic approach to prioritization. Core Values Expected:- Integrity – Always doing the right thing- Teamwork – Collaborating effectively and in good faith- Excellence – Committed to high performance and quality standards- Accountability – Taking ownership of responsibilities and outcomes- Inclusion – Embracing diversity and fostering a collaborative environment

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