Aktuelle Jobs im Zusammenhang mit Pharmaceutical Quality Assurance Specialist - Basel, Basel-Stadt - Lonza
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Pharmaceutical Quality Assurance Specialist
vor 2 Wochen
Lonza is a global leader in life sciences operating across three continents. Our work revolves around science, and we attribute our success to talented individuals working together to devise innovative solutions that help businesses improve people's lives.
Our Team
In Drug Product Services, our successful branch located in Basel and Stein, Switzerland, we have exciting opportunities for you to be part of a group that enables customers to tackle some of the greatest challenges in patient treatment. As a key player in our QA team, you will execute, establish, and maintain the Pharmaceutical Quality Management System at Drug Product Services for manufacturing of sterile products, including combination products.
Your Responsibilities
- Support the organization in compliance topics as part of the QA Compliance team, including CAPAs, self-inspections, KPIs, and assessing GMP training requirements.
- Assist line functions in creating and monitoring quality processes related to the relevant parts of the Quality Management System for combination products.
- Act as an author and approver of corresponding guidance documents and serve as the first point of contact for methods, validation, and testing, as well as acting on any compliance issues for combination products.
- Track GMP status of service providers (e.g., calibration, maintenance, consultants), track SAP material and supplier master data, and actively participate in audits and inspections.
- Represent QA for the packaging team by approving methods, laboratory reports, and development activities.
Requirements
- Academic degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related field.
- Significant working experience in Quality Assurance in pharmaceutical industries and GMP environment, preferably in sterile manufacturing.
- Excellent working knowledge of EU and US GMP regulations relevant for sterile manufacturing and sound knowledge in manufacturing of combination products/ISO 13485/21 CFR 4/MDR.
- Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g., Document Management System), and processes for sterile Drug Product manufacturing, including testing.
- Exceptional communication skills, customer focus, and open-mindedness, with excellent written and spoken English, and basic knowledge of German.
Benefits
We offer a competitive salary range of $80,000 - $110,000 per year, depending on your qualifications and experience, plus benefits that include health insurance, retirement plan, and paid time off.
