QA Teamlead Qualification and Validation 80-100%

Vor 7 Tagen

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 and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Key responsibilities:

- Lead and manage a team of experts and develops them
- Execution the establishment and maintenance of Equipment Qualification System
- Support the implementation of global procedures, related to the CQV
- Ensure the proper qualification of equipment/infrastructure/computerized-systems by ensuring adherence to the corresponding VMP
- Act as first contact for equipment/infrastructure/computerized-systems qualification & maintenance within QA
- Supervision compliance activities like GMP status and trending of equipment, qualification/re-qualification in relation to supplier qualification and audit/inspection/self-inspection observations

Key requirements:

- Academic degree in Engineering, Pharmaceutical Technology, natural science or related field
- Significant working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance
- Extended experience from participation in audits and authorities' inspection
- Very good working knowledge in EU and US GMP regulations relevant for equipment qualification, maintenance and corresponding compliance systems
- Experience in data base assisted maintenance monitoring systems
- Excellent communication and decision-making skills

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: R57150**:

  • Senior QA Expert Qualification

    vor 2 Wochen

    Stein, Schweiz Lonza Vollzeit

    Senior QA Expert – Qualification & Validation – aseptic fill & finish lines (f/m/d) 80-100% at Lonza. Location Stein, AG (Switzerland). Relocation assistance is available for eligible candidates and their families. Job Summary Join our growing Drug Product Services team and help shape the future of pharmaceutical manufacturing! In this role, you’ll...

  • QA Expert – CSV

    Vor 3 Tagen

    Stein, Schweiz Careforce Vollzeit

    Key Responsibilities Ensuring qualification and validation compliance for equipment, infrastructure and computerized systems across aseptic drug product CAPEX projects Reviewing and approving SOPs, URS documentation, validation plans, protocols and reports, including CQV and CSV records Providing QA oversight, guidance and decision-making on qualification...

  • QA Expert – CSV

    Vor 6 Tagen

    Stein, Schweiz Careforce Vollzeit

    Key Responsibilities Ensuring qualification and validation compliance for equipment, infrastructure and computerized systems across aseptic drug product CAPEX projects Reviewing and approving SOPs, URS documentation, validation plans, protocols and reports, including CQV and CSV records Providing QA oversight, guidance and decision-making on qualification...

  • QA Specialist, CSV

    vor 1 Tag

    Stein, Schweiz Coopers Group AG Vollzeit

    Contract duration: 1 year Location: Stein, Aargau, Switzerland The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within the CAPEX project portfolio. Acting as a key Quality partner from project ideation...

  • QA Specialist, CSV

    Vor 5 Tagen

    Stein, Schweiz Coopers Group GmbH Vollzeit

    Contract duration: 1 yearLocation: SteinResponsibilitiesOversee and ensure qualification and validation compliance for equipment, infrastructure, and computerized systems associated with aseptic drug product manufacturing and related utilities.Provide QA support for major CAPEX projects (e.g., new drug product facilities), ensuring quality requirements are...

  • QA Expert – CSV

    Vor 5 Tagen

    Stein (AR), Schweiz Careforce24 Vollzeit

    In this role, you will oversee qualification and validation activities for equipment, infrastructure, and computerized systems within large-scale aseptic manufacturing projects. You act as the quality interface for all CSV- and automation-related topics, guiding project teams and vendors to ensure compliance from concept through implementation. Start Date:...

  • QA Specialist, CSV Automation

    Vor 6 Tagen

    Stein, Aargau, Schweiz Hays Vollzeit

    For our international pharma client we are looking for aQA Specialist, CSV Automation (m/f/d).Duration: 12 months (possibility of extension)Workload: 100%Location: SteinResponsibilitiesEnsure qualification/validation plans and execution of equipment, infrastructure, and computerized systems in line with Quality policies.Approve SOPs, CQV/CSV protocols and...

  • QA Specialist, CSV

    Vor 5 Tagen

    Stein AG, Schweiz Coopers Group AG Vollzeit

    QA Specialist, CSV & Automation m/f/d, Aargau The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within CAPEX project portfolio. Acting as a key Quality partner from project ideation through execution, this...

  • QA Specialist, CSV

    Vor 6 Tagen

    Stein AG, Schweiz Coopers Group AG Vollzeit

    QA Specialist, CSV & Automation m/f/d, Aargau The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within CAPEX project portfolio. Acting as a key Quality partner from project ideation through execution, this...

  • QA Specialist, CSV

    Vor 6 Tagen

    Stein AG, Schweiz Coopers Group AG Vollzeit

    QA Specialist, CSV & Automation m/f/d, Aargau The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within CAPEX project portfolio. Acting as a key Quality partner from project ideation through execution, this...