QC Quality Systems Technical Lead

CPL

Dublin West

“the quality systems tech lead will be part of the team who are responsible for supporting the site quality team with regard to investigations, capas and change controls. the role will support the existing quality team through start up to pai inspection readiness and into commercial finished product testing and release and assure integration of lab and quality systems necessary to operate in accordance with compliance requirements. key responsibilities will include; supporting the following quality systems. change control. investigations. capa’s. owning, managing the process from start to approval of qc related investigations and change controls. ensuring the timely completion of all activities related to these systems. developing, implementing and managing procedures and quality system elements to ensure compliance of all qc activities to all applicable policies, directives, guidance documents and regulatory expectations. supporting the qc labs through global regulatory agency inspections. a degree in science or related discipline is essential along with 5 years’ experience in the biopharmaceutical industry, preferably in quality. a minimum of 3 years’ experience with demonstrated effectiveness using quality systems in a fda and ema regulated environment. knowledge of biotech qc testing is desirable. the candidate will have demonstrated proficiency communicating and collaborating at a variety of levels. in addition, the candidate will have proven success working well in a team environment with flexibility to react to changing business needs, as well as demonstrated problem solving and project management ability.” to find out more please feel free to get in touch with suzanne on 016146152. this job originally appeared on recruitireland.com.

1980 days ago