- To support the Quality Assurance Manager and Quality Assurance Team lead with the quality assurance function relating to packaging operations.
- Electronic Documentation Management System – QUMAS
- Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation.
- QA reviewer of Process Compliance Change Controls
- To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Implement and maintain the company Vendor Qualification Programme.
- Review and approve batch related documentation as required.
- Generation and approval of SOPs.
- Organisation internal (self-inspections) and external QA auditor.
- Liaise with packaging operations / laboratory personnel to ensure regulatory and quality requirements are met.
- Assist with preparation of Submission Documentation in support of license applications and customer requirements.
- Noncompliance reporting and corrective action / continuous improvement implementation.
- Operation of company SAP (ERP System) Quality function as per procedures
- Support the on-going OOS/OOT/ Deviation/CAPA closeout programme.
- 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 perform additional team tasks as agreed to support effective running of the Business.
- Compile and deliver quality based training with the company.
- Health & Safety
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Report any Hazards
- A third level degree incorporating Quality Assurance/ management
- Ideally 3 years Quality Assurance experience in a pharmaceutical packaging environment.
- Experience in packaging validation, Line clearance, Material reconciliation, packaging specifications, control of Artworks
- Experience in Serialization implementation and execution.
- Experience in managing customer and supplier complaints.
- Lead auditor training complete
- Internal audit experience
- Experience with facilitating customer audits
- Careful planning to achieve accurate and timely results to support the packaging plan.
- Ability to define and manage own tasks and schedules
- Multi-tasking, ability to achieve deadlines
- Strong compliance
- Computer Skills to include MS office
- Proven time management skills
- Planning & organizing
- Familiarity with cGMPs relating to pharmaceutical manufacturing
- Working knowledge of EDMS (Electronic Document Management System) and ERP (Enterprise Resource Planning)
- Good attention to detail
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org