We are recruiting for a Senior QA Officer 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.
Responsibilities of this role include :
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 EirGen 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 & SafetyImplement safety requirements as per site documentation including SOPs, Safety Statement and COPsReport any Hazards
The ideal candidate for this role will meet the following criteria :
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