Beschreibung
Our client, pharmaceutical company specilaising in development of biological therapies is currently searching for a QA Operations Manager to manage quality assurance task in the manufacturing of ph I and II clinical batches.RESPONSIBILITIES:
Coordination of batch records for manufactured products for early phases clinical trials.
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, M/WCB records, IND/IMPD and development reports, etc.
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 , deviations
Participate in project teams to support GMP compliance for the projects.
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.
Provide cGMP and associated training to QA and other
REQUIREMENTS:
Master's degree or equivalent
Quality professional with minimum 5 years of hands-on experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
Knowledge of US, EU, cGMP guidelines
Manufacturing USP, DSP and/or Quality Control experience is a plus.
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.
Fluent English is required, French is highly desirable.
Please send your CV
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.