Senior QA, Change Control Specialist

vor 2 Monaten

Visp, 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.

As a member of the QA Projects and Change Controls group in BioAtrium, the Change Control Specialist (f/m/d) supports in QMS GMP compliance (e.g. hosting CCRB, supporting raising and closure of changes), promotes the adherence and continuous improvement of Quality Systems and ensures Quality oversight in the specified area.

Key responsibilities:

Owns quality records such as change controls, CAPAs, investigations, effectiveness checks in line with valid SOPs

Leads the Change Control Review Board (CCRB)and CAPA Review Board (CRB) as required

Hosts change control clinics to support Production, MSAT, validation, CQV and other Quality members with change controls

Authors, reviews and approves GMP-relevant documents and SOPs in the ownership of QA

Supports and participates in internal, customer and regulatory audits

Electronic batch record: recipe review and approval

Support continuous improvements programs to establish effective Quality Management Systems

Key requirements:

Bachelor or Master Degree in life sciences (e.g. chemistry, biotechnology or a related field)

Significant work experience in the GMP-regulated industry; preferably in the following units: Production, QC or QA, Operations

Broad knowledge in Quality standards (e.g. ICH Q7, 21 CFR Part 11

Knowledge of electronic systems such as Delta V, Syncade, SAP, LIMS, Trackwise an advantage

English language skills (written and spoken) are required, German is an advantage

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.

Reference: R61366

  • Senior QA, Change Control Specialist

    vor 2 Monaten

    Visp, Schweiz Lonza AG Vollzeit

    Switzerland, VispToday, 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...

  • Senior QA Specialist

    vor 2 Monaten

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist (Hybrid) - Contamination Prevention & Control Location: VISP Hybrid Working Model (3 days in the office, 2 days WFH) 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...

  • Senior QA Specialist

    vor 1 Monat

    Visp, Schweiz Lonza Vollzeit

    Senior QA (Hybrid) - AnalyticsLocation: VISPHybrid Working Model (3 days in the office, 2 days WFH) 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...

  • Senior QA Specialist

    vor 1 Monat

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist (Hybrid) - Microbiological Quality Assurance and Contamination Control Location: Visp - SwiterzlandHybrid: Working Model (3 days in the office, 2 days WFH) 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...

  • QA Analytics Specialist

    vor 4 Wochen

    Visp, Schweiz Lonza Vollzeit

    QA Analytics Specialist (Hybrid)Location: VISPHybrid Working Model (3 days in the office, 2 days WFH) 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...

  • Senior QA Specialist

    vor 2 Monaten

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist (Hybrid) - Microbiological Quality Assurance and Contamination Control Location: Visp - Switerzland Hybrid: Working Model (3 days in the office, 2 days WFH) 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...

  • QA Analytics Specialist

    vor 1 Monat

    Visp, Schweiz Lonza Vollzeit

    QA Analytics Specialist (Hybrid) Location: VISP  Hybrid Working Model (3 days in the office, 2 days WFH) 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...

  • Senior QA Specialist

    vor 3 Monaten

    Visp, 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,...

  • Senior QA Specialist

    vor 1 Monat

    Visp, Schweiz Lonza Vollzeit

    Quality Operations Senior QA Specialist 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...

  • Senior Quality Assurance Specialist

    Vor 5 Tagen

    Visp, Schweiz Lonza AG Vollzeit

    About the RoleAs a Senior Quality Assurance Specialist at Lonza AG, you will play a critical role in ensuring the quality and compliance of our products and services. This is a challenging and rewarding opportunity to work in a dynamic and global environment.Key ResponsibilitiesQuality Record Management: Own and manage quality records, including change...

  • Senior QA Specialist

    vor 1 Monat

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist (Hybrid) - Microbiological Quality Assurance (Pharmaceutical Microbiologist)Location: VispToday, 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...

  • Senior QA Specialist

    vor 1 Monat

    Visp, Schweiz Lonza Vollzeit

    Quality Operations Senior QA Specialist Today Lonza is a global leader in life sciencesoperating 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...

  • Senior QA Specialist II, Quality System

    vor 4 Wochen

    Visp, Schweiz Lonza AG Vollzeit

    Senior QA Specialist II, Quality System (f/m/d) Switzerland, Visp Senior QA Specialist (Hybrid) - Quality System Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there is no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising...

  • Senior QA Specialist II, Quality System

    vor 4 Wochen

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist (Hybrid) - Quality System Location: VISPHybrid Working Model (3 days in the office, 2 days WFH)Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there is no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that...

  • Senior QA Specialist II, Quality System

    vor 4 Wochen

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist (Hybrid) - Quality System Location: VISPHybrid Working Model (3 days in the office, 2 days WFH)Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there is no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that...

  • QA Project Manager

    vor 3 Monaten

    Visp, Schweiz Manpower Vollzeit

    The Manager of this department is responsible for providing daily oversight, tactical and strategic leadership for a team of QA Project Managers directly supporting the internal and external customers. Key management deliverables are to provide general leadership, guidance and support to ensure QA Project Managers are providing internal and external...

  • Senior QA Specialist II, Quality System

    vor 1 Monat

    Visp, Schweiz Lonza Vollzeit

    Senior QA Specialist (Hybrid) - Quality System Location: VISP  Hybrid Working Model (3 days in the office, 2 days WFH) Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there is no magic formula to how we do it. Our greatest scientific solution is talented people working together,...

  • Senior Quality Assurance Specialist

    Vor 5 Tagen

    Visp, Schweiz Lonza Vollzeit

    About LonzaLonza is a global leader in life sciences, operating across three continents. Our success is built on the talent and dedication of our people, who work together to devise innovative solutions that help businesses improve people's lives.Our CultureWe value our people's careers and empower them to own their work. We encourage creativity and...

  • Microbiological Quality Control Specialist

    Vor 5 Tagen

    Visp, Schweiz Lonza Vollzeit

    Job Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lonza. As a key member of our quality assurance department, you will be responsible for ensuring the quality of our manufacturing facilities, processes, and products.Key Responsibilities:Provide quality oversight for the qualification of manufacturing...

  • Senior QA Specialist, Operations Drug Substance

    vor 1 Monat

    Visp, 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,...