ID EXISTS
POS 4168
Status 8
DJM 1

QA Operations Manager

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: QA Operations Manager (M/F/*) Tasks:Assure that all operations meet cGMP regulationsEnsure the quality of Bulk Drug SubstancesCell bank supporting on shop floor the daily manufacturing, Warehouse and facility operationsReactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformancesCollaboration with product Quality Management for change controlDirect collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating ProceduresSupport quality key metrics and analysisWork cross-functional between the Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments  Qualifications:Business fluent in EnglishKnowledge in cell cultures, purifications processes, operations and business processes within a GMP environmentProficiencies with the Quality systems and business processes associated with automation and integration of testing and production systemsExperience in the qualification of facilities, utilities , equipment and processesExperience in participating in pharmaceutical technology transfer teamDemonstrated ability to work autonomously and lead projectsGood oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectivelyDemonstrated problem solving skillsMust have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.) Nice to have:Business fluency in GermanPrevious experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantageExperience with LEAN, Six Sigma is beneficialPrior experience with facility construction and start-up is an assetExperience in drug substance (or API) and drug product are preferred Frame Data:Start: 01.12.2020Duration: 31.03.2021 (4 month)Capacity: 42 h/week - in shift modelLocation: onsite - Solothurn, Switzerland
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Bemerkungen: WANTED: QA Operations Manager (M/F/*). In case of interest please contact msp@k-recruiting.com or +41 71 577 27 41 Skills: English, German, GMP (Good Manufacturing Practice), Lean Management (Six Sigma, KAIZEN), LIMS (Laboratory Information Management Systems), QA (Quality Assurance)
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Interesse geweckt?
Auf geht's!
Beginn: 01.12.2020
Laufzeit: 4 months
Einsatzort: Solothurn, Switzerland
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