2 jobs found in solothurn

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    • luterbach, solothurn
    • contract
    Do you already have some experience with CAPA ? Do you want to work for a big international biotech company ? You should then read the following lines!Our client, based in Solothurn, is looking for a QA Operations Associate III for a mission of 12 months. The QA Operations Associate III assures all operations meet or exceed cGMP regulations, ensuring high level of quality of Bulk Drug Substance. This position is responsible for providing Quality Assurance input and oversight for Batch release, QA for QC and Warehousing. This position will support quality key metrics and analysis and help operation.This position could also help on management of Project implementation such as a New Product introduction.This role is expected to be cross-functional between the Luterbach Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.As such, the position is expected to have expert level knowledge in 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. RESPONSIBILITIES:- Contribution root cause analysis and corrective action for product and process related non-conformances as SME Q for minor, major and critical deviation- Contribution to Drug Substance batch release documentation package- Support on product quality impact assessment (PQIA) and process/product risk assessment- Standard Operating Procedures review, revision & approval- Collect data for metrics and identification of negative trends- Support as QA SME implementation of project REQUIREMENTS:- Minimum 5 years of quality assurance and/or operation experience in a 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 regulations- Electronic Batch Record and elogbook management will be an asset
    Do you already have some experience with CAPA ? Do you want to work for a big international biotech company ? You should then read the following lines!Our client, based in Solothurn, is looking for a QA Operations Associate III for a mission of 12 months. The QA Operations Associate III assures all operations meet or exceed cGMP regulations, ensuring high level of quality of Bulk Drug Substance. This position is responsible for providing Quality Assurance input and oversight for Batch release, QA for QC and Warehousing. This position will support quality key metrics and analysis and help operation.This position could also help on management of Project implementation such as a New Product introduction.This role is expected to be cross-functional between the Luterbach Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.As such, the position is expected to have expert level knowledge in 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. RESPONSIBILITIES:- Contribution root cause analysis and corrective action for product and process related non-conformances as SME Q for minor, major and critical deviation- Contribution to Drug Substance batch release documentation package- Support on product quality impact assessment (PQIA) and process/product risk assessment- Standard Operating Procedures review, revision & approval- Collect data for metrics and identification of negative trends- Support as QA SME implementation of project REQUIREMENTS:- Minimum 5 years of quality assurance and/or operation experience in a 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 regulations- Electronic Batch Record and elogbook management will be an asset
    • luterbach, solothurn
    • contract
    Do you already have some experience with LIMS ? Do you want to work for a big international biotech company ? You should then read the following lines!Our client, based in Solothurn, is looking for a Junior Quality Systems and Compliance Associate for a mission of 12 months.The main responsibility of the Quality Systems and Compliance Associate is: To act as a QA representative to perform the QA compliance review and approve electronic logbooks.Perform issue of paper logbooks To develop and monitor KPIs, to follow-up on progress as for e.g. documentation, training, audits, action plan...To help the QS&C team with daily activities Key actions: Perform QA Compliance Review of Mfg/QC eLogBookelectronic logbooks for QA compliance review in LIMSCompliance for GMP activities provided by external companies/partners by implementing proper quality document (QuAG, Service Level Ag, Training…)Training follow-up and follow-up through KPIs (Tableau, Power BI…) on Trackwise, PLM (Change control) systemsLead LIMS compliance meetings for follow up actions related to reviews of LIMS electronic logbooks
    Do you already have some experience with LIMS ? Do you want to work for a big international biotech company ? You should then read the following lines!Our client, based in Solothurn, is looking for a Junior Quality Systems and Compliance Associate for a mission of 12 months.The main responsibility of the Quality Systems and Compliance Associate is: To act as a QA representative to perform the QA compliance review and approve electronic logbooks.Perform issue of paper logbooks To develop and monitor KPIs, to follow-up on progress as for e.g. documentation, training, audits, action plan...To help the QS&C team with daily activities Key actions: Perform QA Compliance Review of Mfg/QC eLogBookelectronic logbooks for QA compliance review in LIMSCompliance for GMP activities provided by external companies/partners by implementing proper quality document (QuAG, Service Level Ag, Training…)Training follow-up and follow-up through KPIs (Tableau, Power BI…) on Trackwise, PLM (Change control) systemsLead LIMS compliance meetings for follow up actions related to reviews of LIMS electronic logbooks

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