Our client based in Sligo are looking to hire a QA Manufacturing Compliance Specialist on an initial 12 month fixed term contract.
Ensure that all products leaving Company XXX meet the standards required for marketed and investigational drug products.
Ensure that products and aseptic process simulations manufactured at Company XXX 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).
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.
Third level degree in a science, quality or engineering discipline.
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.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.