To support the Quality Assurance Manager with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.
- To support the Quality Assurance Manager and Quality Assurance Team lead with the quality assurance function for OSD Commercial and R&D products.
- To ensure that all work carried out in EirGen is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Implement and maintain the Vendor Qualification Programme, ensuring robust Quality agreements and adequate CMO Oversight is in place.
- Review batch related documentation as required and ensure OTTR Targets are met.
- Ensure EirGen internal (self-inspections) and external QA audits are complete as per the effective schedules.
- Noncompliance reporting and corrective action / continuous improvement implementation.
- QA Representative for NPI and Product development projects.
- Support the on-going OOS/OOT/ Deviation/CAPA closeout programme, ensure records are compliant and closed on time.
- To support major /critical change implementation across the site for all processes.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- Check own work and that of others for accuracy.
- To assist in the preparation for customer/ regulatory inspections.
- Attend a number of cross functional team meetings as a Quality Assurance representative to assist in running the business.
- To perform additional team tasks as agreed to support effective running of the Business.
- Compile and deliver quality based training within the Quality Team.
- Liaise with operations / laboratory personnel to ensure regulatory and quality requirements are met.
- Assist with preparation of Submission Documentation in support of license applications and/or deficiency responses.
- Health & Safety
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Report any Hazards
Minimum Qualifications & Experience
- A third level degree incorporating Quality Assurance/ management
- A minimum 5 years Quality Assurance experience in the role in a pharmaceutical manufacturing environment.
- Significant experience with desktop and internet-based software applications (e.g. electronic document management system, Trackwise etc)
- Lead auditor training complete
- Internal audit experience
- Experience with facilitating customer audits
- Excellent communication and presentation skills
- Focus on quality and detail
- Careful planning to achieve accurate and timely results
- Ability to define and manage own tasks and schedules
Skills & Behavioural Competencies:
- Multi-tasking, ability to achieve deadlines, work under pressure, coping with more than one conflicting task at once.
- Strong compliance
- Computer Skills to include MS office
- Proven time management skills
- Planning & organizing
- Familiarity with cGMPs relating to pharmaceutical manufacturing
- Excellent Communication skills, both verbal & written.
- Strong attention to detail is critical
- Excellent organisational skills
- Adaptability – maintain effectiveness in varying environments and with different tasks, responsibilities and people.
- Working effectively with team and on own initiative.
Teamwork & Collaboration, Enthusiastic team player, Safety Awareness, Customer Focus, Quality Orientation, Problem Solving / Analysis, Innovation, Initiating Action, Adaptability, Project Management.