Cw Manufacturing Specialist (Senior)

Independent Solutions

Dun Laoghaire, Dublin South

Our client based in Dun Laoghaire is seeking the following for a 12 month contract: 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 Qualifications: 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) OR. * Associate`s Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality. * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment. * 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. Preferred Qualifications: * Experience with investigations into manufacturing deviations and determination fo product impact potential, root cause, and corrective actions. * Project Management experience. * Experience interacting with representatives of regulatory agencies. Candidates must have experience using trackwise, experience writing investigations. More than 3 years experience in a similar position. Must have bio-pharm and GMP background. This job originally appeared on RecruitIreland.com.

2446 days ago