For our biotechnology client, localized in the French part of Switzerland, we are looking for a :
QA Operations - Senior Specialist
As part of the Quality Operations team, you interact with Manufacturing and Development/Technical teams to support manufacturing process development for Investigational product delivery for phase I/II clinical trial on bi/multi specific antibodies.
- Be responsible for the review of facility validation studies, facility SOP and environmental monitoring
- Participate in Raw Material management (specifications definitions, shipping conditions, deviation, etc), interacts with Manufacturing representative for project planning progress
- Coordinate and perform 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, 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 LIR/OOS
- Participate in project teams to support GMP compliance for the projects.
- Shop floor support (Quality Oversight in manufacturing and Quality Control Labs, solve issues real time with operations personnel, etc.)
- 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
- Provide cGMP and associated OJT training to QA and other departments to improve right the first time (RFT), high quality performance
- This position includes domestic and international travels (up to 20%.)
- Master's degree or equivalent in life sciences
- Quality professional with minimum 5-8 years of hands-on experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
- Knowledge of US, EU, PIC/s 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.
- 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 apply on-line. For more information, contact Ms Sophie Darthenay