We have an opportunity for a QA specialist to support a project in QA development stage for production of biologics to be used in clinical trials.
Support activities in acquiring Raw Materials for production of IMP
interacts with manufacturing representative for project planning progress.
Coordinates and performs batch record disposition for manufactured products for Phase I / II clinical trials support.
Responsible for compliance review and approval of the following records: batch records/formulation records, release and stability data, method qualification/validation reports, stability protocols, product specification sheets.
Performs independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending.
Reviews and approves deviations, CAPA’s, change controls, Quality Control LIR/OOS.
Participate in project teams to support GMP compliance for the projects.
SOP generation, review and/or approval.
Lead and assist in continuous improvement projects as assigned interacts with Team Leader, peers, internal customers, external clients, and other cross functional peers to gain alignment on sound quality decisions.
Education And Desired Experience
Master’s degree or equivalent in life sciences
Hands on previous quality experience in similar environment
Knowledge of global/cGMP guidelines
Experience with Quality Systems to include, Batch Record design/review and supporting investigations.
Good organization skills and attention to detail, with strong verbal and written communication skills.
Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.