Purpose of the Job:
To ensure the business units are in compliance with regulatory requirements by timely review and release of batch documentation and conducting process, packing, cleaning and validation activities of all areas against the regulatory standards.
Specific Key Result Areas:
- To ensure that all work carried out is in Compliance with the required standards conforming to company, cGMP, cGLP's, SOP's, regulatory regulations and guidelines, H&S and environmental guidelines.
- New Product/Validation: Quality support for introduction of new products, equipment and facilities.
- To generate, review and conduct process, packing, cleaning and computerized systems protocols and validation reports in line with current regulations and industry best practice, within required timelines.
- Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements. Review and assistance in Laboratory, Complaint, Vendor and Production investigations and reduction of trends in conjunction with relevant departments.
- Quality Systems Development: To develop and improve quality systems by identifying areas for improvement (NVAA's and key variances) and take corrective action as required ensuring continuous improvement in accordance with Company Continuous Improvement Process.
- To deliver Customer Service (both internal and external) through agreed timelines in accordance with quality standards and cost control.
- Participate in CI activities / projects / root cause analysis and solution implementation to enhance the product value streams.
- To conduct simulated HPRA/FDA systems inspections to ensure the company is at all times ready for audit. Conduct audits of Suppliers where necessary.
The successful candidate should possess the following:
- Qualification in a Science Discipline and work experience in Pharmaceutical/Medical Device with two years' experience in a QA environment, preferably in a validation role.
- In depth knowledge and understanding of interpretation of CGMPs, GAMP and regulatory requirements, experience of regulatory inspections and customer audits.
- Experience in CSV and product serialisation activities would be advantageous.
- Understanding of Production and Laboratory systems to effect decisions consistent with business needs.
- Experience of combination devices/pharmaceuticals manufacturing is preferred.
- An understanding of internal/external customer requirements and an ability to respond promptly to needs.
- Ability to participate in day to day activities and projects by providing Quality support.
- Ability to work on own initiative to meet and exceed business objectives.
- Experience with TrackWise, EDMS and strong report writing skills.
- Inhalations and MDPI experience would be beneficial.
