Join a cutting-edge pharmaceutical team where your precision and passion for quality will help shape the future of life-saving medicines!Proclinical is seeking a QC Analyst to primarily focus on data review to support batch release and stability programs.
This position requires on-site presence in Waterford, and candidates must have the right to work in Ireland.Responsibilities:Review data generated in a timely manner to support batch release and stability programs.Perform trending of data and track "Not Right First Time" (NRFT) events.Support the QC laboratory and management with various tasks.Collaborate effectively with other departments, particularly Quality Compliance Specialists and QC Team Leaders, on matters related to raw materials, intermediates, and finished batch releases.Maintain, update, and issue controlled documents such as methods, specifications, and SOPs in compliance with pharmacopeial and regulatory requirements.Assist in training analysts in areas of expertise, new methods, and updated SOPs.Key Skills and Requirements:Proficiency with Empower software is essential.Strong attention to detail and ability to prioritize workload to meet deadlines.Familiarity with checking results against trend limits and specifications, and identifying deviations or lab investigations.Extensive knowledge of cGMP and GDP in a regulated environment.Working knowledge of quality systems in a regulated environment.Excellent accuracy, attention to detail, and interpersonal skills.Strong communication skills and the ability to work both independently and collaboratively.Initiative to see issues through to completion.