Senior Associate QC Systems, Investigations/Change Control in Dun Laoghaire, Dublin
CK Group is recruiting for a Senior Associate QC Systems in Investigations/Change Control to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 6 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: The role provides technical expertise with a focus on Compliance, Continuous Improvement while implementing a Lean Culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.
- Report writing for investigations.
- Own and manage Change Controls through their life cycle for QC.
- Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions.
- Trend analysis of Deviations relating to QC.
- Ensure investigations constantly reflect current requirements and expectations.
- Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings.
- Ensure timely completion of QC Deviations, CAPAs and Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
- Ensure timely completion of each stage of the Analytical Results Assessments in line with the Quality Control Out of Specification and Unexpected Results procedure(s).
- Ensure flow of communication to stakeholders.
- Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP.
- Degree of equivalent in a Science related discipline.
- Experience in a Biotechnology/ Pharmaceutical/ GMP Environment is essential.
- Knowledge of lab operations, analytical lab techniques, commercialisation, and cGMP.
- Experience with Deviations and Laboratory investigations including CAPA identification and implementation.
- Experience in leading Root Cause Analysis would be advantageous.
- Experience in managing and owning Change Controls would be advantageous.
For more information or to apply for this position, please contact Julie on 01438 723500 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 45615 in all correspondence.