Senior Quality Systems Specialist
Posted on Jan 5, 2022 by Real Staffing Group
Job title: Senior Quality Systems Specialist
Location: Swords, North county Dublin.
Reporting to: Quality Manager
Benefits: Salary, Healthcare, bonus of 8%, hybrid working model, excellent career development opportunities.
This is a permanent position will ensure that excellent standards of quality are maintained throughout the business processes and the standards are continuously monitored and improved. The key areas of responsibility for the role holder will lie within the areas of Quality Assurance, Quality Systems & Projects and Auditing. The Senior Quality Systems Specialist will report into the Quality Manager but will work closely with other roles within the Quality Department and Regulatory/Pharmacovigilance, Research & Development and Supply Chain
* Lead internal Quality Improvement Projects relevant to the Quality Management System, Quality Compliance and Quality Assurance.
* Ensure on-going compliance of the Quality Management System.
* Perform other quality related tasks as will be required from time to time
* Ensure that company continues to operate in accordance with European GMP/GDP regulations for drug products, the Medical Device Directive/Regulation and ISO regulations for medical devices, and any other relevant guidelines related to Kora Healthcare business.
* Update and maintenance of Quality documents, such as product specifications, and the preparation and update of SOPs.
* Ensure that internal and external QA documentation is prepared and completed correctly as per the regulations.
* Managing systems relating to QA, including change control, deviations, CAPA, complaints, audits and vendor approval. Chair monthly meetings and provide status updates as requested
* Ensure that internal and external audits schedules are prepared and adhered to as planned, carrying out of internal audits and ensuring that the review, monitoring, reporting of the inspections are completed. Ensuring audit action items are closed within agreed timeframe
* Ensure audits and checks on suppliers and ensuring the review, monitoring and reporting of the audits.
* Final approval of self-inspection report
- 3rd level qualification in a science discipline.
- 5+ years plus of experience in the pharmaceutical and/or medical device industries. Specific experience working in a quality systems or quality assurance role is a requirement for this position.
- 2+ years' experience in CAPA management is essential.
- User experience of electronic Quality Management Systems (previous experience of system administrator would be an advantage)
- Strong background in the application of ISO 13485 and GMP/GDP standards.
- Previous experience in regulatory inspections, supplier audits and customer audits.
If you are interested in applying or have any questions in regards to this role contact me directly and we can organise a call to discuss further.
Look forward to hearing from you.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales