3 jobs found in Solothurn

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    • solothurn, solothurn
    • permanent
    Do you have a strong quality background in a manufacturing environment ? Do you want to develop your career in a renowned life science company ? You should then read the following lines!One of our clients, based in the Solothurn area, is looking for a Senior Quality Engineer for a permanent position. Tasks:You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.You review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory, Quality and Process systems.In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).You work with the senior Quality Engineering Team to identify/revise/develop and implement complex Quality systems that can be global in scopeYou ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)You interact with regulatory agencies directly during audits as well as providing input into such documents as regulatory filings (may be expected to act as primary author for sections of filings)Profile:You have a bachelor’s Degree in a relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer ScienceYou bring a broad level of experience in a pharmaceutical or biotech manufacturing environment. With at least a solid previous experience within Quality Assurance, Validation or another related function. Automation/MES or related functions are preferred.You have and maintain knowledge of relevant FDA/EMA regulations and compliance.You have experience in validation of production equipment or cleaning utilities, automation systems and knowledge of production methodology involved in bio-pharmaceutical production.You have the ability to work in cross-functional teams Do those lines sound familiar to you ? Do not waste any second and apply now!
    Do you have a strong quality background in a manufacturing environment ? Do you want to develop your career in a renowned life science company ? You should then read the following lines!One of our clients, based in the Solothurn area, is looking for a Senior Quality Engineer for a permanent position. Tasks:You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.You review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory, Quality and Process systems.In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).You work with the senior Quality Engineering Team to identify/revise/develop and implement complex Quality systems that can be global in scopeYou ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)You interact with regulatory agencies directly during audits as well as providing input into such documents as regulatory filings (may be expected to act as primary author for sections of filings)Profile:You have a bachelor’s Degree in a relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer ScienceYou bring a broad level of experience in a pharmaceutical or biotech manufacturing environment. With at least a solid previous experience within Quality Assurance, Validation or another related function. Automation/MES or related functions are preferred.You have and maintain knowledge of relevant FDA/EMA regulations and compliance.You have experience in validation of production equipment or cleaning utilities, automation systems and knowledge of production methodology involved in bio-pharmaceutical production.You have the ability to work in cross-functional teams Do those lines sound familiar to you ? Do not waste any second and apply now!
    • luterbach, solothurn
    • contract
    Do you want to work in a biotech company? Do you have a first experience in a GMP environment? You should then read the following lines! Our client, based in Solothurn, is looking for a Manufacturing Associate for a 1 year-mission. JOB SUMMARY:Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.Executes manufacturing processing steps and/or manufacturing support activities using electronic batch records RESPONSIBILITIES:- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation- Actively participates in training activities, managing their individual training plan. Trains other associates as required.- Executes validation protocols- And other job duties that may be assigned from time to time. REQUIREMENTS:• High school diploma or equivalent experience and typically 3-5 years relevant experience in related or non-related industry or 2-3 years experience in Pharma/Biotech industryOR• Bachelor degree in related filed with 1-2 years professional experienceOR• Bachelor degree in not related field and typically 3-4 years experience• Languages: English B1, German and/or French an assetShift work is required for this position Do not waste any minutes, apply now! We are looking forward to receiving your application.
    Do you want to work in a biotech company? Do you have a first experience in a GMP environment? You should then read the following lines! Our client, based in Solothurn, is looking for a Manufacturing Associate for a 1 year-mission. JOB SUMMARY:Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.Executes manufacturing processing steps and/or manufacturing support activities using electronic batch records RESPONSIBILITIES:- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation- Actively participates in training activities, managing their individual training plan. Trains other associates as required.- Executes validation protocols- And other job duties that may be assigned from time to time. REQUIREMENTS:• High school diploma or equivalent experience and typically 3-5 years relevant experience in related or non-related industry or 2-3 years experience in Pharma/Biotech industryOR• Bachelor degree in related filed with 1-2 years professional experienceOR• Bachelor degree in not related field and typically 3-4 years experience• Languages: English B1, German and/or French an assetShift work is required for this position Do not waste any minutes, apply now! We are looking forward to receiving your application.
    • selzach, solothurn
    • contract
    Do you want to work in a medical device company? Do you have at least 3 years experience in QA in Life Sciences? You should then read the following lines!Our client, based in Selzach, is looking for a Senior QA for a mission until january 2022 to support with Quality System Compliance TASKSAssure compliance oversight to make sure QMS is working properly. One important task is to assess regional/global documents being updated and decide if we need to adopt our local procedures.Be able to decide if an update of a local document/procedure is required or not and then initiate execution of the update with the SME.Internal Audit and inspection managementProcess ownership, continuous improvementSME for internal audit (IA): planning, execution and follow up for internal audits in Selzach Distribution Center; hosting of IAs for QA processes Purchasing ControlLocal purchasing control SME, Link with Franchise in Zuchwil, who execute purchasing control.This role owns the Selzach specific Service Level Agreements and must support any request to add and delete a supplier to this list (includes GxP assessment of the supplier and then the communication with team in Zuchwil)QEM approvalOversight on the Quality event management.Decision with the process owner in case of doubts if Quality Issue (QI) has to be opened or not; Quality Leader for QIs coming from Früh; take ownership and support Operations with QIs for the warehouse zones.QEM SupportSupport QEM SME in case of workload increaseAct as compliance support for OPS partners for all QIs in the owned warehouse zonesRepack & Relabelling supportSupport with Batch record verification for Repack Relabelling activities (execution) QUALIFICATIONS• University/Bachelor Degree or Equivalent in a scientific field is required• 5+ years of related experience in areas such as Quality Operations, Compliance, Supplier Quality, Quality Systems, etc.• Fluent German is strongly preferred Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    Do you want to work in a medical device company? Do you have at least 3 years experience in QA in Life Sciences? You should then read the following lines!Our client, based in Selzach, is looking for a Senior QA for a mission until january 2022 to support with Quality System Compliance TASKSAssure compliance oversight to make sure QMS is working properly. One important task is to assess regional/global documents being updated and decide if we need to adopt our local procedures.Be able to decide if an update of a local document/procedure is required or not and then initiate execution of the update with the SME.Internal Audit and inspection managementProcess ownership, continuous improvementSME for internal audit (IA): planning, execution and follow up for internal audits in Selzach Distribution Center; hosting of IAs for QA processes Purchasing ControlLocal purchasing control SME, Link with Franchise in Zuchwil, who execute purchasing control.This role owns the Selzach specific Service Level Agreements and must support any request to add and delete a supplier to this list (includes GxP assessment of the supplier and then the communication with team in Zuchwil)QEM approvalOversight on the Quality event management.Decision with the process owner in case of doubts if Quality Issue (QI) has to be opened or not; Quality Leader for QIs coming from Früh; take ownership and support Operations with QIs for the warehouse zones.QEM SupportSupport QEM SME in case of workload increaseAct as compliance support for OPS partners for all QIs in the owned warehouse zonesRepack & Relabelling supportSupport with Batch record verification for Repack Relabelling activities (execution) QUALIFICATIONS• University/Bachelor Degree or Equivalent in a scientific field is required• 5+ years of related experience in areas such as Quality Operations, Compliance, Supplier Quality, Quality Systems, etc.• Fluent German is strongly preferred Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 

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