Quality Assurance Specialist - Dun Laoghaire
Jenni at CK Group is recruiting for a Quality Assurance Specialist to join a company in the biotech industry at their site based in Dun Laoghaire on a 12 month contract basis.
Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The QA Specialist is a position within the Quality Regional Work Cell in Europe reporting to the Senior Manager, QA. The QA Specialist will be required to understand and grasp a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes. In addition to routine Quality Assurance duties, the QA Specialist may be assigned specific oversight and responsibility for key processes improvements with the Regional Work Cell and the wider External Supply Quality Organisation.
- Manage and own NC records for External Quality
- Manage and own CAPA records for External Quality
- Manage and own Change Control records internal to External Quality
- Manage and drive Quality records to closure independently
- Perform tactical batch disposition activities in support of lot release
- Provide tactical information to the networks (i.e., metrics to management, data analysis, trending, periodic monitoring, APR)
- Escalate risks or roadblocks to management
- Drive timely decision making using decision making principles
- Drive continuous improvements and company first mindset
- Prior quality and manufacturing experience in biotech or pharmaceutical industry
- Bachelor's Degree in a Science Field
- cGMP Experience
- Ability to oversee multiple projects simultaneously
- Able to successfully manage workload to timelines
- Ability to negotiate a position after taking feedback from multiple sources
- Demonstrated ability to consistently deliver on-time, and high-quality results
- Ability to operate in a matrixed or team environment
- Understanding of the applicable manufacturing/testing processes
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45611 in all correspondence.