This leading global biotech organisation maintains a broad portfolio of products across Neuroscience, Oncology, Rare Diseases and Consumer Healthcare. They are seeking an experience QA professional to join the Quality team at their manufacturing facility in North Dublin. This role will initially be a contract, with a high likelihood of becoming permanent.
Duties and responsibilities of the QA Chemist will include:
- Implement and maintain quality systems in line with global and company specific standards.
- Oversee change control activities within the relevant group, ensuring that all changes which may have an impact on quality and compliance within the department are properly evaluated.
- Oversee investigations, OOS and unplanned events workflows, ensuring they are performed correctly.
- Support internal and external audits. Assist with vendor audits and external inspections of the Dublin site.
- Support manufacturing activities by performing area and equipment inspections, batch record reviews, and batch release based on testing performed / overseen by the relevant department.
- Support the Quality oversight for API Contract Manufacturers for development compounds.
- Participate in CMC teams and other cross functional teams as necessary.
The successful candidate will have skills and experience in the following:
- in a scientific, technical or engineering discipline.
- 5 years relevant experience working in a GMP environment.
- 2 years relevant experience working in a QA role is preferable.
- Knowledge of cGMP as it relates to API Development activities (Requirements of EMEA, FDA at different Phases of clinical development).
- In-Depth knowledge of quality systems and their maintenance / implementation in API sites.
- Team-working and communication skills.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.