Senior Associate QC Systems- Investigations/ Change Control- Dun Laoghaire
CK Group is recruiting for a Senior Associate QC Systems - Investigations/Change Control to join a company in the Pharmaceutical 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.
Our client is looking for a Senior Associate in QC Systems who will be Leading, coordinating, contributing to and undertaking activities pertaining to Quality Control Deviations, Corrective/ Preventive Actions, Analytical Results Assessments and Change Control records.
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. The role may involve carrying out additional work functions that are not described in this specification but are associated with the role.
- All activities within the companies Quality System associated with QC Deviations, CAPA records, Analytical Results Assessments and Change Control.
- 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.
- Hold a third level qualification in a Science related discipline.
- Minimum 4 years' experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
- Knowledge of lab operations, analytical lab techniques, commercialization, 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 Natasha 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 45877 in all correspondence.