Senior Quality Engineer

Engineering
Ref: 427 Date Posted: Tuesday 02 Aug 2022
LinkedIn ShareShare

 

All of our jobs are based in Louth/ Meath/ Cavan/ Monaghan/ North Dublin.

Overview of Role: Our client based in North Dublin is seeking a Senior Quality Engineer & Deputy Responsible Person Quality on a full-time permanent basis.

Main purpose of job: Quality & Continuous Improvement Manager & Responsible Person (RP) Quality: This person will work primarily with the customer to ensure a smooth supply chain for our customers.

Main tasks/responsibilities:

Quality:

Pro-actively work with all customers to ensure the company is continually meeting and exceeding their requirements.

Keep appraised of all new developments, technologies pertaining to company development goals and foster continuous improvement ethic.

Liaise with all functions to continuously interrogate the systems & processes eliminating waste and improving performance.

Provide support to internal departments regarding process development and process risk analysis and assess new processes for effective quality control.

Ensure processes enhance overall Quality performance and assure that all customer and regulatory agency requirements are met.

Drive solutions to improve consistency in KPl's using Continuous improvement & Lean manufacturing tools.

Ensure daily, weekly and monthly monitoring on all aspects of quality system and customer complaints is conducted Deputy RP Support RP in relation to

Attend and participate in the GDP training provided by the RP and other external organisations

Review and train on all procedures relating to distribution activities covered under the WDA

Ensure that a system is in place to manage documentation and ensure that adequate records are maintained in a secure manner

Ensure the principles of Good documentation Practices are applied to documentation

Ensure that Change Control systems are established and implemented.

Ensure there is a Falsified Medicines procedure in place to assist in identification of potential

Ensure there is an adequate training system in place and assist in training the staff in GDP principles, Legislation and HPRA guidance including the detail of a WDA, the Role of the RP, Medicinal products information, Falsified Medicines, QMS, Train the trainer, and other relevant topics. In addition, ensure that initial and continuous training for all personnel involved in distribution activities are implemented and the training system is effective.

Ensure audit of the quality system is completed on a regular basis by periodic review of QMS and operational procedures for regulatory compliance through internal audit system

Ensure that there is a qualified warehouse with a temperature monitoring system available which can provide temperature alerts as required

Ensure there is a qualified warehouse management system available for use to ensure product traceability and enable FEFO

Assist in the development and review of validation documentation for systems at the facility as required

Ensure there is a system in place to handle returned, rejected or recalled product

Ensure that procedures are in place for receipt of products, replenishment, pick and pack and dispatch, quarantine, release, reject, return, recall and disposal of product and other critical operations

Ensure that the operations do not compromise the quality of medicines by ensuring that the systems are in place to monitor storage of the product at the premises and during transport in cases where the company is responsible for transport

Ensure procedures are in place for management of audits and inspections and the issues identified are acted upon in a timely manner

Where contract organizations are used, responsible for review and approval of the Quality Agreements/Service Level Agreements and ensuring that contractors are qualified and performing as required by the agreement.

Ensure Quality agreements with clients are in place and clearly define all responsibilities in relation to GDP. Provide clients with reports in relation to Quality KPls as required in relation to their activities.

Ensure that clients and their suppliers to site are legitimate and hold the appropriate licences. In addition, dependant on Quality Agreements, ensure customers are approved in compliance with the GDP requirements.ie bona-fides.

 

Essential Requirements:

Third level qualification in Science, Engineering, Applied Maths or equivalent

Relevant experience in a similar role in a fast paced, high tech manufacturing environment

Computer Literate

Proficient in SPC & Statistics

Green Belt certified

Knowledge and experience of Lean/ Six Sigma practices and principles

Knowledge of ISO 13485

Knowledge of GDP & HPRA Requirements Behavioural Competencies

Experience in supply chains

Knowledge experience in Project Management

Experience in Lean/6 Sigma.

SAP Knowledge

Validation experience

If you are interested in the above role, please apply to job reference KR/571 on www.recruitmentbureau.com.

At The Recruitment Bureau, we respect your privacy; your CV will not be forwarded to a client company without your consent.