Overview
QA Manufacturing Compliance Specialist Jobs in County Sligo, Ireland at NIRAS Ireland
Title: QA Manufacturing Compliance Specialist
Company: NIRAS Ireland
Location: County Sligo, Ireland
Who We Are:
NIRAS Ireland specializes in design and delivery of process-driven projects. We provide Project Management, Engineering Design, Project and Managed Service resources to the Food & Beverage, Life Science and Advanced Process Manufacturing sectors across Ireland and internationally.
We are currently recruiting a QA Manufacturing Compliance Specialist (Biologics) to join our client’s manufacturing facility in co. Sligo.
12 mth contract – 100% onsite.
Rotating day and evening shift weekly.
Days: 07:00 – 15:00 Evenings: 15:00 – 23:00.
Responsibilities:
• Ensure that all products leaving the manufacturing meet the standards required for marketed and investigational drug products.
• Ensure that products and aseptic process simulations manufactured at the manufacturing meet the requirements of the end users, regulatory authorities and of the company.
• 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.
