Kelly Services are recruiting for an experienced manufacturing specialist for a South Dublin based pharmaceutical company. on a temporary contract up to April 2022.
The manufacturing specialist will be primarily responsible for resolving fill/finish nonconformances (NCs). Specific responsibilities include but are not limited to:
- Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner
- Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
- Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded
- Assisting as needed in audit by external agencies in answering questions related to NCs
- Performing other duties as required by Manufacturing Management Basic
- Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
- Detailed technical understanding of fill/finish operations
- Experience participating in and leading cross-functional teams
- Experience in managing multiple, competing priorities in a fast-paced environment
- Strong technical writing and presentation skills * Ability to be flexible and manage change
- Ability to communicate and collaborate with technical and management staff
- Experience with investigations into manufacturing deviations and determination for product impact potential, root cause, and corrective actions
- Project Management experience
- Experience interacting with representatives of regulatory agencies
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.