Job Description:
We are seeking a Quality Assurance (QA) Manufacturing Compliance Specialist to join our team on behalf of a leading pharmaceutical company based in Sligo, Ireland. This is an initial 12-month contract role.
Key Responsibilities:
* Ensure all products leaving the manufacturing site meet strict quality and regulatory standards for marketed and investigational drug products.
* Verify that products and aseptic process simulations manufactured comply with requirements from end-users, regulatory authorities, and the company.
* Provide quality and compliance oversight and assistance to the Operations function to manufacture products in accordance with all site policies and procedures.
* Conduct quality oversight during aseptic processing of products, including observation of aseptic interventions.
* Lead or assist in investigations arising from product or manufacturing process non-compliance.
* Audit and review completed batch records.
* Review manufacturing logs as required.
* Complete quality reviews of operations documentation, such as standard operating procedures (SOPs), job safety training manuals (JSTMs), risk assessments, and line clearance activities.
* Verify incoming raw materials, including product status maintenance as needed.
* Support the stability program, including sample pulls, weekly checks, protocol generation, and finished product status maintenance.
* Manage quality logs, QA holds, and sample requests.
* Conduct daily walk-throughs of manufacturing areas to ensure compliance and identify opportunities for improvement.
* Drive continuous improvements and simplify site processes and procedures to maintain compliance.
* Perform other support tasks as deemed necessary.
Requirements:
* Bachelor's degree in a science, quality, or engineering discipline.
* Prior experience in a quality role is preferred.
* At least three years of experience in a quality/operations role in a highly regulated Good Manufacturing Practice (GMP) environment, preferably in biologics manufacturing.
* Familiarity with aseptic processing gained within a quality or operations role is desirable.
* Strong knowledge of regulatory requirements is essential.
Candidates should submit their application