Paragon Europe in Malta is seeking to recruit a Design Quality Officer for one of our clients within the Healthcare Industry on a full-time basis.
The Design Quality role will help the company in identifying and ensuring that the right information is delivered to its patients all over the globe. This is obtained by helping in creating company’s Labels at excellent quality.
- The Design Quality officer will ensure that all labels are updated according to the Regulatory Affairs requirements for each and every country the company supports;
- Design control and risk management activities applied to the labelling of medical packages;
- Ensure that design control and risk management are performed in line with the company’s applicable procedures;
- Responsible for executing day-to-day activities to support Global Labeling Operations;
- Understand and leverage the company’s quality practices within your area of responsibility.
Essential Duties and Responsibilities:
Artwork Control (Primary Function):
- Carry out quality control of artwork to ensure high quality and compliant artwork is submitted;
- Ensure that Design Artworks have been updated according to the mark up provided;
- Ensure all typesetting of packaging components (including the text, graphics, chemical structures, bar codes etc…) are as per guidelines and standard;
- Be proficient in using the software “Docuproof” in order to ensure that artworks are updated correctly;
- Have a basic knowledge of Adobe software’s like “Photoshop”, “Indesign” & “Illustrator”;
- Proper Storage and archiving of documents as per local procedure.
Document Control (Supporting Function):
- Trained in GDP, the ability to maintain clear traceability with multiple revisions & multiple sign-offs;
- Work with labelling operations to finalize markups;
- Ensure that documentation is in line with FDA Regulations;
- Carry uploads of official documents for approval in company’s Systems for document release;
- Ensure that all packages are approved as per procedure and filed accordingly.
General Duties and Responsibilities:
- Ability to support and drive business targets associated with the labelling operations team (cycle time, accuracy, compliance);
- Ability to support Global facilities/entities;
- Ensure to maintain a 6S working environment in the working area;
- When required, the incumbent shall provide support to the coordinator on project improvements;
- The incumbent is also responsible to ensure that all procedures related to his/her responsibilities are in line with corporate requirements and that any corrective actions triggered by Corporate/Internal/Other audits are always implemented within the established time frames;
- The incumbent is also responsible to consider the aspects of Environment Health and Safety procedures to ensure that all activities within his role will support EHS targets and will not jeopardize the health and safety of employees and environment;
- The incumbent must also ensure that all documentation and practices related to her role are in compliance with good laboratory and documentation practices.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Experience of performing design control and document proofreading in accordance to ISO standards;
- Exceptional organizational skills and the ability to support business targets;
- Experience in using IT Process Oriented Systems;
- Experienced in using “Docuproof” or similar software’s;
- Be meticulous and attentive to detail;
- Experience in quality control would be considered an asset;
- Good interpersonal and communication skills;
- Fluent in English (both written and verbal);
- Fluency in any other language is considered an asset.
Education and/or Experience:
Paragon Europe is an innovative, international EU affairs, advisory and compliance company with head offices in Malta and Brussels. From its inception, Paragon Europe has striven to realise excellence by competing with cutting edge peers in the ultra-competitive market of EU funding. Paragon Europe works with both private and public organisations, NGOs, universities, educational institutes and agencies offering various services related to European funded programmes such as Horizon 2020, Erasmus+, Youth Workers, COSME, PON/POR and more. We assist these organisations with the sourcing and implementation of EU funded projects and tailor our services to each individual requirement ensuring positive results every time. Besides advising public and private organisations on EU funding, Paragon staff also assist good organisations to become great through business and financial advice.
- Diploma or Advanced level of education is essential. Must be ICT proficient user.
- Or 1 to 3 years’ experience working in the quality control department.