01 524 1466 | email@example.com
Are you focused on excellent standards of quality being maintained throughout the business processes? Do you possess the ability to work well both on your own initiative and also within a team environment? Do you have excellent interpersonal, communication and presentation, strong analytical and problem solving skills? If so, this Quality Officer role is the right one for you!
About the Employer:
Our client is a well established company based in County Dublin. They are currently recruiting a Quality Officer for their growing team. This is a challenging opportunity for those who are proactive and have a hands-on approach and want to develop in their career.
- Competitive salary and up to 8% bonus (split across company and individual objectives).
- Holidays 21 days per year (excluding bank holidays). There is no forced shutdown aside from the compulsory period Christmas Period approx 3 or 4 days.
- Head office ‘thank X its Friday’ held on the Friday closest to pay day each month (20th)
- Formal on-site and off-site training over.
- Each Friday is a casual Friday (dress down code)
- Company Conference hold at an offsite location on a quarterly basis which includes a company dinner as a team (generally in the locality).
- Desk in open office plan.
The Successful Candidate:
- You have a 3rd level qualification in a science discipline.
- You have 3 years minimum experience in the medical devices and / or pharmaceutical industries in a quality environment.
- You possess a strong background in the application of ISO 13485 and GMP/GDP standards.
- You have strong organisational skills, ability to prioritise work and systematic approach to tasks.
- You are highly motivated self-driven and “can-do-attitude” and enjoy and thrive in a fast paced environment.
As Quality Officer, some of your duties & responsibilities will include:
- Working with Packaging Designers and Suppliers, generating new/revised product packaging and labelling artwork
- Maintaining and updating packaging specifications in both in soft copy and hardcopy
- Maintaining and updating Quality Documents associated with product packaging
- Preparation and updating of company SOPs relevant to product packaging and labelling
- Coordinating the review and approval of packaging artwork and labelling in line with Standard Operating Procedures
- Carrying out and co-ordinating assigned internal audits and ensure the review, monitoring, reporting of the inspections. Ensuring audit action items are closed within agreed timeframe.
- Assisting with audits and checks on suppliers and ensure the review, monitoring and reporting of the audits.
- Assisting with preparation for Health Authority and Notified Body inspections and preparing regulatory inspection responses.
- Monitoring and reporting Key Performance Indicators associated with Vendors/Suppliers
- Assisting with the preparation and regular review of Technical Agreements with all relevant suppliers.
- Maintaining and updating Quality Documents associated with Vendors
- Maintaining Vendor management system ensuring all necessary quality documentation associated with each vendor is updated as required and properly filed.
- Updating and review SOPs as required via eQMS.
- Ensuring updated SOPs are reviewed and signed by all relevant departments.
- Ensuring the correct revision of SOPs is in circulation at all times.
- Managing superseded and obsolete SOPs correctly.
- Controlling and maintaining the document archive and sample retention system.
- Providing administrative and/or technical support with respect to preparation, assembly, filing and distribution of information relating to product registrations, compliance and pharmacovigilance.
- Assisting with the preparation of the Quality Management Reviews and Product Quality Review. Ensuring that training plans are implemented and training records are maintained.
- Generating and reporting of relevant Quality metrics.
For further information or if you wish to apply for the position of Quality Officer please send your CV in word format to firstname.lastname@example.org
To apply for this job email your details to email@example.com.