Quality Assurance Operations Associate

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Quality Assurance Operations AssociateDuration: Contract until the end of the year initially

DescriptionThe Quality Assurance Operations Associate assures that all operations meet or exceed cGMP regulations, ensuring the quality of the Bulk Drug Substance, supporting the daily manufacturing and facility operations. The position will reactively provide support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances.The holder will collaborate with product Quality Management for change control. This is accomplished by direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures. This position will support quality key metrics and analysis. As such, the position is expected to have knowledge in cell culture, purifications process, operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.You work on the field, having an oversight over the manufacturing operations from a quality point of view and the electronic batch record review (QRM). You will review and approve Standard Operating Procedures (SOP) and you will perform ad hoc sampling and testing.You report to the Quality Assurance Operations Supervisor and work cross-functional with different quality units (QC, Product Quality, Corporate Quality, QA). You work in a 5-shift model alongside the manufacturing team, within this you will work with other Quality Assurance Operations Associate colleagues and your Supervisor. RequirementsPrevious experience in quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.Good experience of process design and improvement.Strong working experience with GxP regulationsElectronic Batch Record and e-logbook management will be an assetGood oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectivelyDemonstrated ability to work autonomously and lead projectCandidates with experience in drug substance (or API) and drug product are preferred.Proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)Ability to work in shift model including during the weekendSthree Switzerland is acting as an Employment Business in relation to this vacancy.