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Lead QA Specialist, Infrastructure & Utilities 80-100% (m/f/d)

Lead QA Specialist, Infrastructure & Utilities 80-100% (m/f/d)

Lead QA Specialist, Infrastructure & Utilities 80-100% (m/f/d)

Lead QA Specialist, Infrastructure & Utilities 80-100% (m/f/d)

Lonza AG

Bio- und Nanotechnologie

Visp

  • Vollzeit
  • 38.500 CHF – 47.500 CHF (von XING geschätzt)
  • Vor Ort
  • Aktiv auf der Suche

Lead QA Specialist, Infrastructure & Utilities 80-100% (m/f/d)

Über diesen Job

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 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.

The r ole:

The QA Infrastructure and Logistics group provides key QA oversight and support for the Switzerland-VISP site. This group supports the site utilities, warehousing, and movement of raw materials and products in and out of facilities.

T his position will focus on implement ing and manag ing robust cross-functional support of legacy and new facilities. You will be res ponsible for assuring Quality Assurance of Lonza’s site s and facilities , whilst ensuring shared utility systems and logistics areas are carried out by Lonza's standards, industry best practices, and the requirements of national and international regulatory agencies .

Key responsibilities:

  • Provide QA support for Project and Operations internal customers in the following areas: GMP & Compliance and c lean utilities .

  • Provide Quality Assurance oversight to the site and facilities focusing on shared utility systems .

  • Organize and lead Deviation Review Boards for Utilities & Logistics related deviations .

  • Review and assess Change Requests and Corrective and Preventative Actions (CAPA) .

  • Review and approve standard operation procedures for shared utility systems .

  • Review and assess GMP impact of utility alarms and incidents .

  • Assist with operational readiness activities and assess their risks in the relevant areas .

  • Support internal and external audits , and inspections and r epresent the Quality function at relevant meetings .

  • Leads or supports local implementation of global Quality policies and standards in his/her area of responsibility .

Key requirements:

  • Academic degree (Bachelor or higher) in Pharmaceutical Sciences/ Biochemistry/ Engineering/ Chemistry or related field .

  • Relevant work experience in Quality Assurance and/or Production, Engineering, and/or Quality Control in pharmaceutical industries in cGMP environment .

  • Knowledge of Swiss, EU, and US GMP regulations relevant to audit/inspections and compliance systems.

  • Strong verbal and written communication skills in English, German is an advantage.

  • Ability to communicate quality and compliance requirements to varying levels and functions of the organization.

  • Strong collaborative mindset and the ability to build relationships quickly.

  • Strong organizational skills, and ability to balance multiple priorities simultaneously.

  • Ability to solve problems, understand details and strategic picture, providing practical solutions.

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.

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Lonza AG

Bio- und Nanotechnologie

Köln, Deutschland

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