Job Description

Senior Quality Systems Specialist - North Dublin

Ref No: AM17541

Co. Dublin, Ireland

Competitive salary

Senior Quality Systems Specialist - North Dublin.

This a permanent hybrid role: 3 days in office and 2 days from home.

In this role you will ensure that excellent standards of quality are maintained throughout the business processes at the company and that 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.

Key Duties:

Quality Management System:

• Ensure that the 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 the business.
• Update and maintenance of Quality documents, such as product specifications, and the preparation and update of SOP's.
• 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.
• Logging product complaints, following up with suppliers on investigations in conjunction with the Manufacturing Specialist and close investigations within agreed timeframes.
• Monitor and ensure Technical Agreements are in place and maintained with all relevant suppliers and service providers for out-sourced activities. Final approval of new and revised Technical Agreements.
• From a Quality perspective ensuring the stability program testing is completed and results are reported on time.
• Maintain compliance by working closely with the Qualified Person (QP) for medicines and Responsible Person (RP) for GDP as appropriate.
• Reporting of and maintaining Quality metrics.
• Administrator on electronic software system including Trackwise and Glams software systems.
• Lead and implement Quality improvements projects.
• Assist with internal Batch release activities.


Auditing:

• Ensure that internal and external audit 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 reports
• Assisting with preparation for Health / Competent Authority and Notified Body inspections and prepare regulatory inspection responses.
• Facilitating inspections by Third Parties.
• Ensure follow-up with auditees with satisfactory and timely closure of audit actions.

General:

• 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.

Interested applicants should have a background in a scientific discipline or the pharmaceutical industry.

The successful candidate will possess the following:

• 3rd level qualification in a science discipline.
At least 6-8 years' 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.
• At least 2 - 4 years’ experience in CAPA management.
• 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.
• Strong organisational skills, ability to prioritise work and systematic approach to tasks.
• Highly motivated self-driven and “can-do-attitude”.
• Enjoy and thrive in a fast-paced environment.
• Excellent interpersonal, communication and presentation skills, strong analytical and problem-solving skills.
• Applicants must also possess the ability to work well both on their own initiative and also within a team environment.
• High level of proficiency in Microsoft Office in particular, Word and Excel.

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