Quality Assurance Associate II

vor 3 Wochen


Solothurn, Solothurn, Schweiz Experis Switzerland Vollzeit
Quality Assurance Associate II (BBBH611264) Solothurn, Switzerland

Description:

The Associate III within the Integrated Downstream Quality Operations team is part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn site is intended to operate with a fully integrated electronic batch record for all commercial, clinical and PPQ campaigns.

  1. Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured by Biogen.
  2. Reviews and approves GMP Engineering and Manufacturing documents during both project and operational phases of the site, specifically related to procedures, work instructions, CAPAs, deviations, change control, equipment (work orders, P&IDs, qualification protocols, calibration deviations, etc.).
  3. Partners with Manufacturing, Manufacturing Sciences, Process Engineering, Automation SMEs during deviation management and investigations.
  4. Participates in the monitoring and release activities for Column Packing / Unpacking and Chromatography Review.
  5. Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New product introduction.
  6. Participates in batch record review and close out in view of batch release.

Minimum Requirements:

  1. Bachelor's degree in a relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 5 years of experience in a pharmaceutical or biotech manufacturing environment.
  2. Master's degree in a relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 3 successful years of experience in a pharmaceutical or biotech manufacturing environment.
  3. Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
  4. Demonstrated ability to work autonomously with cross-functional team members.
  5. Strong presentation and organizational skills.
  6. Demonstrated writing skills.
  7. Demonstrated problem-solving skills.
  8. English B1 as a minimum.

Contact: Alba Jansa

Whatsapp Business: +41 76 811 63 99

Eligibility:

Yes, I am currently eligible to work (work permit/visa/citizenship) in the country to which I am applying. No, I am not currently eligible to work (work permit/visa/citizenship) in the country to which I am applying.

#J-18808-Ljbffr

  • Solothurn, Solothurn, Schweiz K-Recruiting Life Sciences Vollzeit

    QA Associate (M/F/D)Tasks:Handling of shopfloor oversight over the manufacturing operations, eBR and elogbook review (LIMS and samples, QRMs…) (60%)Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured.Reviews and approves GMP Engineering...


  • Solothurn, Solothurn, Schweiz Proclinical Staffing Vollzeit

    Direct message the job poster from Proclinical StaffingSenior Research Associate @ Proclinical Staffing - DACH | EngineeringProclinical is seeking a dedicated Quality Control Associate to ensure operations align with cGMP regulations. This role involves supporting quality metrics and analysis and requires collaboration across various departments. The ideal...


  • Solothurn, Solothurn, Schweiz Experis Switzerland Vollzeit

    Experis Switzerland - Job DescriptionJob Title: Quality Assurance SpecialistWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our Integrated Downstream Quality Operations team at Experis Switzerland. As a key member of our team, you will be responsible for ensuring the quality and integrity of our downstream...


  • Solothurn, Solothurn, Schweiz Proclinical Staffing Vollzeit

    Proclinical Staffing is seeking a dedicated professional to join their team as a Quality Control Associate. This role plays a crucial part in ensuring operations adhere to cGMP regulations, supporting quality metrics and analysis, and fostering collaboration across various departments.To be successful in this position, the ideal candidate will have a...


  • Solothurn, Solothurn, Schweiz Biogen International GmbH Vollzeit

    Sr Associate I, Integrated Upstream Quality Operations- Full-time- Region: EU+/Canada- Department: QualityJob DescriptionAbout This Role:As a Senior Associate I within the Integrated Upstream Quality Operations team, you will play a pivotal role in the Quality Department of our cutting-edge Large-Scale Manufacturing facility in Solothurn, Switzerland. Your...


  • Solothurn, Solothurn, Schweiz Biogen, Inc. Vollzeit

    Sr Associate I, Integrated Upstream Quality OperationsFull-timeRegion: EU+/CanadaDepartment: QualityAbout This Role:As a Senior Associate I within the Integrated Upstream Quality Operations team, you will play a pivotal role in the Quality Department of our cutting-edge Large-Scale Manufacturing facility in Solothurn, Switzerland. Your focus will be on...


  • Solothurn, Solothurn, Schweiz K-Recruiting Life Sciences Vollzeit

    Direct message the job poster from K-Recruiting Life SciencesWe unite the people who make our world healthier by placing top experts with life sciences companies worldwide. Fast and reliably, with the perfect…QC Associate (M/F/D)Tasks:Management (preparation, moving, shipping) of QC test, stability & retain samples including trade and GMP compliant...


  • Solothurn, Solothurn, Schweiz Proclinical Group Vollzeit

    Proclinical is seeking a dedicated Quality Control Associate to ensure operations align with cGMP regulations. This role involves supporting quality metrics and analysis and requires collaboration across various departments. The ideal candidate will have a proactive approach to identifying discrepancies and experience in GxP manufacturing is...


  • Solothurn, Solothurn, Schweiz Proclinical Staffing Vollzeit

    Proclinical is seeking a dedicated Quality Control Associate to ensure operations align with cGMP regulations. This role involves supporting quality metrics and analysis and requires collaboration across various departments. The ideal candidate will have a proactive approach to identifying discrepancies and experience in GxP manufacturing is...


  • Solothurn, Solothurn, Schweiz Proclinical Staffing Vollzeit

    Proclinical Staffing is currently seeking a motivated Quality Control Associate to join their team. In this pivotal role, you will play a significant part in upholding cGMP regulations, driving quality improvements, and enhancing collaboration among departments.As a Quality Control Associate, you will be accountable for ensuring all operations align with...


  • Solothurn, Solothurn, Schweiz Proclinical Staffing Vollzeit

    This exciting opportunity at Proclinical Staffing seeks an experienced professional to fill the role of Quality Control Associate. As a key member of the quality team, you will be responsible for ensuring seamless operations by upholding cGMP regulations.We are looking for a skilled individual who can effectively identify and resolve discrepancies,...


  • Solothurn, Solothurn, Schweiz Experis Switzerland Vollzeit

    The Team is now looking mainly for candidates experienced with Upstream Processing in Pharma / Biotech Production.Also, candidates ideally working with aseptic techniques and having aseptic knowledge.Shifts RequiredContact: Alba JansaName: Please include your first and last name.Email: Please provide your email address.Phone: Please include your country...


  • Solothurn, Solothurn, Schweiz Proclinical Staffing Vollzeit

    This challenging role as Quality Control Associate at Proclinical Staffing requires a detail-oriented and organized professional to ensure seamless operations in accordance with cGMP regulations.As a critical member of the quality team, you will be responsible for identifying and addressing discrepancies, collaborating with other departments, and maintaining...

  • IT-Qualitätsmanager

    Vor 4 Tagen


    Solothurn, Solothurn, Schweiz AMEOS Holding AG Vollzeit

    Berufsbild:Wir suchen eine technisch interessierte Persönlichkeit, die sich auf die Verantwortung als IT-Qualitätsmanager in unserem Unternehmen einlässt. In dieser Rolle sind Sie verantwortlich für die Führung und Entwicklung unseres Teams im Bereich IT Quality Assurance.Aufgabenbereiche:Führung der direkt unterstellten Mitarbeiter und deren Personen-...

  • Manager IT QA

    vor 2 Wochen


    Solothurn, Solothurn, Schweiz AMEOS Holding AG Vollzeit

    Im Bereich Corporate IT suchen wir am Standort Solothurn eine technisch interessierte und engagierte Persönlichkeit alsArbeitsort:Werden Sie Teil eines stark wachsenden Unternehmens und gestalten Sie die Zukunft unserer bahnbrechenden Medizintechnik-Lösungen mit.Ihre HauptaufgabenPersonelle und fachliche Führung der direkt unterstellten Mitarbeitenden...


  • Solothurn, Solothurn, Schweiz Skilled Recruitment Solutions GmbH Vollzeit

    Direct message the job poster from Skilled Recruitment Solutions GmbHSenior Recruitment Consultant - Skilled Recruitment Solutions GmbHLocation: Canton of SolothurnAre you ready to push the boundaries of water technology and make the semiconductor industry more sustainable? We are looking for a Water Treatment Engineer (m/f/d) who doesn't just think in terms...


  • Solothurn, Schweiz Swisslinx Vollzeit

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from SwisslinxIT Recruiter @ Swisslinx | Connecting Talent to OpportunitiesIndustry: Biotechnology / PharmaceuticalsAbout the RoleWe are seeking a highly motivated Associate III – Integrated Downstream Quality Operations to join our Quality Department at our...


  • Solothurn, Schweiz K-Recruiting Life Sciences Vollzeit

    QA Associate (M/F/D)Tasks:Handling of shopfloor oversight over the manufacturing operations, eBR and elogbook review (LIMS and samples, QRMs…) (60%)Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured.Reviews and approves GMP Engineering...


  • Solothurn, Schweiz Ypsomed Vollzeit

    In the Quality Management, Regulatory & Medical Affairs area in the Quality Assurance department, we are looking for a customer-oriented and quality-conscious personality in the Production Management Team at the Solothurn site as a **Quality Assurance Manager **| 80 - 100%**: Ref. No. 6219 - Location: - Solothurn- | HybridHelp us bring to market...


  • Solothurn, Schweiz Ypsomed Vollzeit

    Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Solothurn eine kundenorientierte und qualitätsbewusste Persönlichkeit als **Quality Assurance Manager | **100%**: Ref-Nr. 6367 - Arbeitsort: - Solothurn- , Burgdorf- | HybridHelfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt...

  • QA Associate

    vor 4 Wochen


    Solothurn, Schweiz Proclinical Staffing Vollzeit

    Proclinical is seeking an Associate III to join the Integrated Downstream Quality Operations team. This role involves engaging in quality operations and engineering activities for downstream manufacturing and equipment at a large-scale facility. The focus is on ensuring product safety, efficacy, and purity through comprehensive quality assurance...


  • Solothurn, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Proclinical is seeking an Associate III to join the Integrated Downstream Quality Operations team. This role involves engaging in quality operations and engineering activities for downstream manufacturing and equipment at a large-scale facility. The focus is on ensuring product safety, efficacy, and purity through...


  • Solothurn, Schweiz Michael Page Vollzeit

    For our client, a leading international pharmaceutical company with modern offices in the canton of Solothurn, we are currently looking for a Quality Assurance Specialist (m/f/d) to support the Integrated Downstream Quality Operations Team, to start immediately for the next 7 months.DescriptionThe selected candidate will be responsible for the following task...


  • Solothurn, Schweiz Michael Page International (Switzerland) SA Vollzeit

    Prestigious pharmaceutical company7-months project with extension possibilityAbout Our ClientFor our client, a leading international pharmaceutical company with modern offices in the canton of Solothurn, we are currently looking for a Quality Assurance Specialist (m/f/d) to support the Integrated Downstream Quality Operations Team, to start immediately for...


  • Solothurn, Schweiz Experis Vollzeit

    SUMMARY: Performs and documents daily Weigh & Dispense operations and internal material flow management activities in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents. Ensures compliance to cGMP as well as maintaining equipment and facilities. The associate is detail-oriented with strong...


  • Solothurn, Schweiz ROCKEN Vollzeit

    Unser ROCKEN-Partner nimmt in der Uhrenindustrie eine führende Position ein. Inspiriert von einem einzigartigen Erbe, mit unvergleichlichen technischen, industriellen und menschlichen Vorzügen, hat unser ROCKEN-Partner sein über viele Jahrzehnte erworbenes Wissen eingesetzt, um die Zukunft aktiv zu gestalten. Heute baut das Unternehmen auf seinem grossen...


  • Solothurn, Schweiz ROCKEN Vollzeit

    ROCKEN® ist in der digitalen Rekrutierung von Talenten und Experten spezialisiert und zählt alle etablierten Unternehmen aus jeglichen Branchen zu den Partnern. Diese sind national sowie international tätig und bieten dem zukünftigen Talent eine spannende Herausforderung. Mit dem Anspruch, die besten Talente zu rekrutieren, beraten wir unsere Partner...


  • Solothurn, Schweiz Recrutis Vollzeit

    **Job Summary**: Are you ready to play a pivotal role in our mission? As a Supervisor Manufacturing, you'll lead a dynamic team of Manufacturing Associates, ensuring the seamless execution of daily operations while upholding the highest standards of cGMP compliance and safety protocols. Your leadership will be instrumental in driving operational excellence...


  • Solothurn, Schweiz Recrutis Vollzeit

    **Job Summary**: Are you ready to play a pivotal role in our mission? As a Supervisor Manufacturing, you'll lead a dynamic team of Manufacturing Associates, ensuring the seamless execution of daily operations while upholding the highest standards of cGMP compliance and safety protocols. Your leadership will be instrumental in driving operational excellence...


  • Kanton Solothurn, Schweiz Hays Vollzeit

    **My duties** - Meet or exceed cGMP regulations ensuring the quality Bulk Drug Substance, cell bank supporting on shop floor the daily manufacturing, Warehouse and facility operations - Support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances - Collaborate with...

  • Material Planner

    vor 3 Wochen


    Solothurn, Schweiz Actalent Vollzeit

    Our client, a key player in the industry, is looking for a Material Planner to support manufacturing planning for both clinical and commercial programs at their site, while collaborating with Manufacturing, Warehouse, Scheduling, Quality, and Procurement areas.Responsibilities:Responsible for raw materials planning and inventory control activities.Supports...

  • Prpject Manager

    vor 3 Wochen


    Solothurn, Schweiz LHH Vollzeit

    Are you ready to power up your career with a global leader in energy solutions and energy technologies? Our client is dedicated to pioneering cutting-edge solutions that redefine the future of energy. Join a team of passionate engineers and unleash your potential to shape a brighter tomorrow. **Your profile**: - Education background in Power Engineering or...


  • Solothurn, Schweiz Johnson & Johnson Vollzeit

    **_Caring for the worldone person at a time” _**inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo. **DePuy Synthes **Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the...