Job Summary:
We are seeking a highly motivated Quality Assurance Specialist to join our team at Biologics Ballytivnan. The successful candidate will be responsible for ensuring that all products meet the required standards for marketed and investigational drug products.
The ideal candidate will have a third-level degree in a science, quality or engineering discipline and a minimum of three years' experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing and aseptic processing is highly desirable.
Responsibilities:
* Ensure all products leaving Biologics Ballytivnan meet standards for marketed and investigational drug products.
* Ensure products and aseptic process simulations manufactured at Ballytivnan meet requirements of end users, regulatory authorities and company.
* Provide quality and compliance oversight and assistance to Operations function of company to manufacture products in compliance with site policies and procedures.
* Provide quality oversight during aseptic processing of products, including aseptic intervention observation.
* Lead/assist 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.
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.
This role will involve working on-site % and will follow a 2-cycle shift pattern, Monday to Friday, involving one week of days and one week of evenings.