Team Lead QA Ops

vor 2 Monaten

Stein, Schweiz Lonza Vollzeit

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Key responsibilities:

- Execute establishment and maintenance of the Quality Oversight at DPS Manufacturing (aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques)
- Lead and manage a team of at least 8 quality operations experts and develop them
- Review and approve protocols and reports for e.g. APS, holding time studies, cleaning studies, equipment/room qualification as applicable including documents in electronic systems (e.g. batch records, SOPs)
- Document Authoring, Review and approval including documents (e.g. batch records, SOPs)
- Supervise and execute GMP compliance activities like changes, non-conformities, document management, e.g. last approver of major deviations for manufacturing incl. executing the deviation review board and open requests to re-open TrackWise records via the TW support team
- Provide practical and theoretical trainings for e.g. Trackwise changes, personnel qualification
- Guide team members in line with Lonza values and behaviors including objective setting performance evaluations, development planning and participate in the recruiting process
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps
- Establish and implement training and development plans
- Ensure effective use of resources (budget, time, personnel, systems)
- Counsel and support Sterile Production line functions, customers and groups in DPS like manufacturing, formulation and process development, business development in GMP compliance related issues in area of expertise
- Write/Contribute to internal compliance policy and/or comment to regulations
- Management and reporting of KPIs
- Represent QA Operations in inspections, audits and local and global initiatives
- Perform/support self-inspections and audits as required
- Enforce adherence to GMP for sterile manufacturing/aseptic filling (acts as fist contact concerning compliance issues / quality alerts for local and shared systems)
- Perform other duties as assigned
- Deputy of Head of QA Operations-Growth Project as required

Key requirements:

- University or academic degree (e.g. Masters) in Chemistry, Biology, Pharmacy or equivalent
- 10-15 years of professional experience in Quality Assurance and/or Quality Control in a manufacturing environment within the pharmaceutical Industry, preferably in Sterile manufacturing of drug products
- Proven record of 2-4 years of people management, of more than 6-8 direct reports
- Possess in-depth knowledge of Good Manufacturing Practice (GMP); sterile drug product aseptic manufacturing, Annex I regulations and ICH guidelines
- Experience in Swissmedic inspections, FDA inspections, and other health authorities is desired
- Exceptional leadership and people management skills. Interpersonal savvy - capable of managing multiple points of view and building partnerships
- Excellent communication, presentation and listening skills are a must for this role
- Ability to handle ambiguity and complexity of Growth Projects is a plus
- Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
- Fluency in English (spoken and written) is a must. At least B1 Level (spoken and written) in German is required

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

  • QA Compliance Postgraduate

    vor 1 Monat

    Stein, Schweiz Novartis Vollzeit

    **Summary**: Start date: As soon as possible Duration: 1 year Languages: business-level English and fluent German required **About the Role**: **Your responsibilities will include**: - Ensure all activities are in compliance with cGxP, incl. data integrity - Support with the preparation of Annual Product Quality Review activities according to Novartis...

  • QA Expert Equipment Qualification and Validation

    vor 5 Monaten

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Qm / QA Ims-manager (M/w/d)

    vor 5 Monaten

    Stein, Schweiz G+E GETEC Holding GmbH Vollzeit

    AARGAU (STEIN) - VOLLZEIT - UNBEFRISTET - HSEQ Sie wollen etwas bewirken? Dann sind Sie bei uns genau richtig! Wir suchen Menschen, die unsere Vision teilen und Energie für mehr haben. Unsere Werte spornen uns an: Wir leben Partnerschaft. Wir schaffen Wegweisendes. Wir machen’s einfach! Mit smarten Energie - und Infrastrukturdienstleistungen für...

  • QA Manager

    vor 5 Monaten

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • QA Associate

    vor 5 Monaten

    Stein, Schweiz Datalynx AG Vollzeit

    For our client, a well-known pharmaceutical company in Basel, we are looking for a QA Associate (M/F/d). **Background** Standard activities or routine tasks e.g. batch records reviewer, etc. Supportive project work. Support the timely release of GMP relevant documents and batches. Support departmental projects and objectives according to agreed timelines...

  • Electrical Instrumentation Lead

    vor 5 Monaten

    Stein, Schweiz Universal-Job Vollzeit

    **Beschreibung** Reports to: CAPEX Lead ADC Dolphin / Technical Project Manager -Support and Review of Design Documents related to their Discipline -Leads and Coordinates Sensor Risk Assessment according Project Standards -Ensures Swiss and Project Standards are kept. -Coordination of Operations SMEs, Global SMEs and Design Team -Oversee Deliverables in...

  • CQV Lead Consultant

    vor 3 Wochen

    Stein, Schweiz Consultys Vollzeit

    Job description: Responsibilities: As part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks include but are not limited to: Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans. Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering,...

  • Building Service Utilities Lead

    vor 5 Monaten

    Stein, Schweiz Universal-Job Vollzeit

    **Beschreibung** Reports to: CAPEX Lead ADC Dolphin / Technical Project Manager -Support and Review of Design Documents related to Building Services and Utilities -Ensures Swiss and Project Standards are kept. -Coordination of Operations SMEs, Global SMEs and Design Team -Oversee Deliverables in their Discipline to support and ensure timely completion of...

  • CSV Engineer

    vor 3 Wochen

    Stein, Schweiz Hays Vollzeit

    Responsibilities:Acting as subject matter expert (SME) on following Lonza CQV / CSV standardsCSV person of contact of the assigned system till the handover to the operation organizationParticipate to the system impact assessment as CSV SMEDefine with EMR and Package Units vendor the most appropriate design for vertical integration in the Lonza...

  • CQV Technical Lead with Fill Finish Experience

    vor 3 Wochen

    Stein, Schweiz Callista Vollzeit

    We are seeking a highly skilled Contract CQV (Commissioning, Qualification, and Validation) Technical Lead with extensive Fill Finish experience. The successful candidate will be responsible for leading CQV activities for Fill Finish processes, ensuring compliance with regulatory standards and company procedures. Key Responsibilities: Lead and execute CQV...

  • Cqv Technical Lead with Fill Finish Experience

    vor 2 Monaten

    Stein, Schweiz Callista Vollzeit

    **Key Responsibilities**: - Lead and execute CQV activities for Fill Finish equipment and processes. - Develop and review validation protocols (IQ, OQ, PQ) and reports. - Coordinate with cross-functional teams to ensure timely completion of CQV deliverables. - Troubleshoot and resolve technical issues related to Fill Finish processes. - Ensure adherence to...

  • Project Lead Commercial Qc

    vor 5 Monaten

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Post Graduate Qc

    vor 5 Monaten

    Stein, Schweiz Novartis Vollzeit

    **Summary**: Für unsere Produktionsstätte in Stein suchen wir eine/n Postgraduate in Bereich analytische Qualitätskontrolle mit kürzlich abgeschlossenen Bachelor oder Master im Life Science Bereich. In dieser Rolle unterstützt du die Freigabelabore für analytische Testung von Biotech Drug Product. Zusätzlich wirst du den Labor Lead team in...

  • Jr. Process Expert Cgt

    vor 5 Monaten

    Stein, Schweiz Novartis Vollzeit

    385593BR **Jr. Process Expert CGT (temp)**: Switzerland **About the role** **Process Expert CGT (temp), Stein, Switzerland** **43 million!** the total no of patients we reached in 2022 through our collective efforts to reimagine medicine and make a real difference to the lives of patients around the world. As a Jr Process Expert you will support PU by...

  • Sr. Technical Program Lead

    Vor 2 Tagen

    Stein, Schweiz Hays Vollzeit

    Responsibilities:Coordinate and track the technical specification and standards creation and updates associated with the targeted areas for improvement, including guidance documents, procedures, and policy where necessary.Collaborate with internal SMEs and standard owners to progress the technical specification and standard review, ensuring alignment with...

  • Software Engineer

    vor 2 Wochen

    Stein am Rhein, Schaffhausen, Schweiz ERNE AG Holzbau Vollzeit

    As a Software Engineer (Backend), you will be responsible for designing, developing, and maintaining the backend infrastructure of our systems. You will work closely with our cross-functional teams to deliver high-quality software solutions.Responsibilities:Design and develop scalable, efficient, and secure backend systemsCollaborate with front-end engineers...

  • Technical Project Manager Automation

    vor 5 Monaten

    Stein, Schweiz Universal-Job Vollzeit

    **Beschreibung** Reports to - CAPEX Lead ADC Dolphin Overall Design Coordination of the Project Automation and IT Team - Overall Design Coordination of IT and OT - Focus on critical path - Design Note Coordination incl schedule and cost analysis - Oversee project plans to ensure timely completion of activities. - Collaborate with cross-functional teams to...

  • Technical Project Manager

    vor 5 Monaten

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Logistiker (M/w/d)

    vor 1 Monat

    Stein, Schweiz Datalynx AG Vollzeit

    Für unseren Kunden, ein renommiertes Pharmaunternehmen in Stein, suchen wir eine/n Logistiker (m/w/d). **Hintergrund** Als Lagerlogistik-Spezialist (m/w/d) sind Sie für die effiziente und ordnungsgemäße Verwaltung und Organisation unseres Lagerbereichs verantwortlich. Ihr Ziel ist es, einen reibungslosen Ablauf der Lagerprozesse zu gewährleisten, die...

  • Produktionsmitarbeiter Visuelle Inspektion

    Vor 5 Tagen

    Stein, Schweiz Datalynx AG Vollzeit

    Für unseren Kunden, ein renommiertes Pharmaunternehmen in Stein, suchen wir einen Produktionsmitarbeiter (m/w/d). **Hintergrund** Die Aufgaben umfassen die Durchführung und Überwachung von Produktionsprozessen gemäss GMP-Standards, die präzise Dokumentation von Chargenprotokollen sowie die Sicherstellung der Produktqualität. Verantwortlichkeiten...