QC Associate - Dublin, Ireland
Posted on Jan 19, 2019 by Anonymous
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 person appointed will join the QC Laboratory team. The position will involve working with the QC Chemical s team to ensure all testing is performed as per regulatory requirements, cGMP and site procedures.
- Extensive Testing of NPI engineering and PPQ batches.
- Monitoring of site water systems Maintenance.
- Trouble Shooting Method Validation.
- Possible training of QC Chemistry Laboratory colleagues.
- Laboratory Investigation Report writing, Laboratory Housekeeping duties and maintaining GLP standards.
- Assisting in regulatory audits, commitment tracking and follow up.
- Bachelors degree in a Chemistry (or related subject) discipline.
- Ideally Biopharmaceutical QC experience would be preferred.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
- Knowledge of Continuous Improvement is beneficial.
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 KA44260 in all correspondence