Description
Pharmaceutical company based in North Dublin is seeking a QA Supervisor.Role summary
- The QA Supervisor will be responsible for leading the QA Team to meet defined goals and objectives, ensuring that all quality management systems are operating efficiently and in-line with cGMPs, including Eudralex volume 4, ICH Quality Guidelines and other market requirements
- They must exhibit strong leadership, coaching and motivational skills and must have 5 years of Pharmaceutical experience including Quality Assurance experience or related discipline.
Main responsibilities
- Provide active support and participation in managing the Pharmaceutical Quality System
- Manage the day to day activities of a team of QA professionals
- Measure quality KPIs and promote continuous quality improvements
- Provide support to quality event management e.g. complaints handling, deviations and CAPA management
- Change controls including label and other artwork changes
- Prepare and manage QA documentation and reports
- Provide support in regulatory submissions and upkeep of dossiers
- Effectively liaise with Management and other Team members
- Provide QA input and support for projects including validation
- Actively participate in the training and development of subordinates
- Manage the self inspection program
- Manage the site wide GMP training program
- Engender a perpetual state of inspection ready for regulatory compliance
- Co-ordination of the Annual Product Quality Review program
Person profile:
- Minimum a Bachelor's degree in a relevant scientific discipline
- 5 years of Pharmaceutical experience including Quality Assurance experience or related discipline. However, a combination of experience and/or education will be taken into consideration.
- Experience in a Supervisory capacity would be an advantage.
- Thorough knowledge of EU GMP's
- Demonstrated success in leading teams and completing projects
- Good understanding of manufacturing systems
- Working knowledge of Cosmetic and Medical Device regulations would be an advantage.
- Audit management expertise, preferably with a recognised certification
- Experience in supporting regulatory submissions
- Team player with strong interpersonal skills and a good communicator both verbally and written
- Computer literate including working knowledge of MRP and quality tolls (e.g. SAP and Trackwise) systems
If you are interested in this great opportunity and would like to hear more about the company and role please contact me Anna Mooney or apply below with an up to date CV.