Job Description
QA Manufacturing Compliance Specialist (Biologics) rotating day and evening shift An career advancing opportunity has arisen for a QA Compliance Specialist within a Pharmaceutical Manufacturing leader based in the West of Ireland Responsibilities • Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures. • Provide quality oversight during the aseptic processing of products, including aseptic intervention observation. • Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance. • Review/Audit of completed Batch Records. • Review of Manufacturing Logs as required. • Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments) • Completion of Line Clearance activities. • Completion of Incoming Raw Material checks, including product status maintenance (as required). • Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required). • Finished product status maintenance, including labelling as required. • Administration of Quality Logs, e.g. QA Hold, Sample Request. • Lead operations floor daily walk around of manufacturing areas. • Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times. • Other support as deemed necessary. Requirements • Third level degree in a science, quality or engineering discipline. • Ideally previous experience in a quality role • A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable. • Experience in aseptic processing gained within either a quality or operations role is highly desirable. • A strong knowledge of regulatory requirements is required