This generics and speciality branded pharmaceutical organisation have a large portfolio of products across pharmaceuticals, biologics and medical devices. Due to continued success and growth, there is an opening at their Global HQ in South Dublin for a Senior QA Specialist.
This individual will be responsible for the quality oversite of CMO/CPO Quality Operations and Quality Systems (all aspects), and CAPA. They may manage projects or be assigned SME/Process owner for an internal Quality System.
Duties and responsibilities of the Senior QA Specialist will include but are not limited to:
- Contributing to the preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics and department reporting.
- Preparing and/or reviewing controlled documents (e.g. SOPs) required for compliance.
- Providing quality guidance on product transfers and validations.
- Taking the lead in resolving investigations, deviations, and corrective actions, and other quality issues with each CMO.
- Assisting with all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems.
- Leading an individual system and assisting in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities.
- Contributing to and maybe leading operational teams in the development, management, and improvement of quality systems and procedures.
- Participating in cross functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing etc.
You will have skills and experience in the following:
- Minimum BSc in a scientific field
- 5+ years relevant industry experience with strong knowledge of the concepts and theories of the QA/compliance discipline
- Strong knowledge of all current state, federal, and local US and EU standards and regulations
- Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
- Strong verbal and communication skills
- Ability to handle multiple priorities in a fast-paced environment
- Attention to detail
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.