Kate Edwards at CK Group is recruiting for a QC Associate to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis.
The Company: 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.
The Location: 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 Role: Primary duties include:
- Use compendial testing methods to test finished products such as pre-filled syringes and vials.
- Test for appearance, colour, clarity, protein concentration, water testing, utilities, etc using methods such as US Pharmacopeia-National Formulary (USP/NF), European Pharmacopoeia (EP), etc.
Additional responsibilities include:
- Plan and Perform non-core chemical analytical high volume NPI testing activities in adherence with agreed testing turnaround time.
- QC Representative for NPI activities and routine Product meetings.
- Assist with activities related to QC projects and/or QC tasks within Site projects.
- Manage all sample management activities related to NPI activities throughout the site.
- Create/own and approve protocols, sample plans, SOP and documentation related to NPI.
- Responsible for their own training and safety compliance.
- Sample shipments and temperature monitoring activities for NPI activities.
- LIMS data coordination of non-core (NPI) activities.
- Bachelor's degree in a Science related field is required.
- GMP laboratory experience in the pharmaceutical or medical device industry.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
- Experience in compendial testing methods.
- Ideally have experience in laboratory systems such as sample management LIMS, Velquest/Smartlab, Empower software etc.
For more information or to apply for this position, please contact Kate Edwards on 01246 457739 or email email@example.com. 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 46949 in all correspondence.