(Senior) Quality Assurance Expert for pharmaceutical QMS and combination products 80-100%

Vor 5 Tagen

Stein AR, Schweiz Lonza Group Ltd. Vollzeit

(Senior) Quality Assurance Expert for pharmaceutical QMS and combination products 80-100% (m/f/d)

Apply locations CH - Stein CH - Basel time type Full time posted on Posted 2 Days Ago job requisition id R61580

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.

For Drug Product Services (DPS), our successful DP focused branch located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for Quality Assurance Expert for pharmaceutical QMS and combination products.

Key responsibilities:

  1. Executes, establishment and maintenance of the Pharmaceutical Quality Management System at Drug Product Services for manufacturing of sterile products including combination products.
  2. Supports the organization in compliance topics as part of the QA Compliance team including but not limited to CAPAs, self-inspections, KPIs, assess GMP training requirements.
  3. Assist the line functions in the creation and monitoring of quality processes related to the relevant parts of the Quality Management System for combination products.
  4. Act as author and approve corresponding guidance documents and be first contact concerning methods, validation and testing and acting in any compliance issue for combination products.
  5. Tracking GMP status of service providers (e.g. calibration, maintenance, consultants) tracking SAP material and supplier master data.
  6. Active participation in audits and inspections and following up.
  7. Act as QA representative for the packaging team by approving methods, laboratory reports and development activities.

Key requirements:

  1. Academic degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences or related field.
  2. Significant working experience in Quality Assurance in pharmaceutical industries and GMP environment preferable in sterile manufacturing.
  3. Excellent working knowledge in EU and US GMP regulations relevant for sterile manufacturing and sound knowledge in manufacturing of combination products / ISO13485 / 21Cfr4 / MDR.
  4. Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g. Document Management System) and processes for sterile Drug Product manufacturing incl testing.
  5. Exceptional communication skills as well as customer focus (intern/external).
  6. Excellent knowledge of written and spoken English, basic knowledge of German.
  7. Open minded, self driven, independent.
  8. Structured working attitude.

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.

#J-18808-Ljbffr

  • Senior QA Expert Manufacturing Release 80-100%

    Vor 5 Tagen

    Stein (AR), Schweiz Lonza Group Ltd. Vollzeit

    Senior QA Expert Manufacturing Release 80-100% (m/f/d) page is loaded Senior QA Expert Manufacturing Release 80-100% (m/f/d) Apply locations CH - Stein time type Full time posted on Posted 20 Days Ago job requisition id R59178 Today, Lonza is a global leader in life sciences operating across three continents. While we work...

  • Senior QA Expert for QC 80

    Vor 4 Tagen

    Stein (AR), Schweiz Lonza Group Ltd. Vollzeit

    Senior QA Expert for QC 80 - 100% (m/f/d)Apply locations CH - Stein time type Full time posted on Posted 2 Days Ago job requisition id R59092Today, 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...

  • (Senior) QA Expert Compliance

    Vor 5 Tagen

    Stein (AR), Schweiz Lonza Group Ltd. Vollzeit

    (Senior) QA Expert Compliance (f/m/d)Apply locations CH - Stein time type Full time posted on Posted 4 Days Ago job requisition id R64563Today, 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,...

  • Postgraduate Quality Assurance Operations

    Vor 4 Tagen

    Stein, Schweiz Novartis Vollzeit

    **Summary**: At Novartis Stein Aseptics facility we are producing 40 million units of pre-filled syringes, vials and ampules per year and deliver them as medicines to more than 150 countries. Become part of a demanding, dynamic and quality-oriented team and support us in the quality of innovative, biotechnological products in one of Novartis' most important...

  • Postgraduate Quality Assurance Operations

    vor 4 Stunden

    Stein, Schweiz Healthcare Businesswomen’s Association Vollzeit

    Job Description SummaryAt Novartis Stein Aseptics facility we are producing 40 million units of pre-filled syringes, vials and ampules per year and deliver them as medicines to more than 150 countries. Become part of a demanding, dynamic and quality-oriented team and support us in the quality of innovative, biotechnological products in one of Novartis' most...

  • Process Expert

    Vor 2 Tagen

    Stein, Schweiz Novartis Vollzeit

    80million! This is the number of sterile products that are processed in our workplace per year. As part of the production team, you will play a key role in manufacturing and ensuring the highest product quality for millions of patients in more than 150 countries around the world. For the Process Unit (PU) Galenic we are looking for a motivated and committed...

  • Team Lead QA Ops 80-100%

    Vor 5 Tagen

    Stein (AR), Schweiz Lonza Group Ltd. Vollzeit

    Team Lead QA Ops 80-100% (m/f/d)Apply locations CH - Stein time type Full time posted on Posted 2 Days Ago job requisition id R62496Today, 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,...

  • Team Lead QA Ops 80-100%

    Vor 4 Tagen

    Stein (AR), Schweiz Lonza Biologics Porriño SLU 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,...

  • Student Internship in Pharmaceutical Manufacturing

    vor 17 Stunden

    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,...

  • QA Expert Equipment Qualification and Validation

    Vor 3 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...

  • QA Lead

    vor 1 Tag

    Stein (AR), Schweiz Panda International Vollzeit

    We are seeking a dedicated and skilled QA Lead to join the Global Quality Engineering team for our leading CDMO in Switzerland. This role offers a unique opportunity to lead a transformative project within a globally renowned organization. With a long-term perspective, this position provides career growth and exposure to high-impact operations in the...

  • Msat Expert Drug Product

    vor 17 Stunden

    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 Manager

    vor 1 Woche

    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...

  • Jr. Process Expert Cgt

    Vor 2 Tagen

    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...

  • QA Manager

    vor 1 Woche

    Stein, Schweiz Universal-Job Vollzeit

    In this role, you will support the QA/QC oversight and do QA driven projects on requests. Your accountabilities will include: - Ensure compliance according to internal quality standards, relevant regulatory requirements and the filed product quality standards - Ensure QA monitoring of the allocated products in the QC organization - Manage all quality aspects...

  • QA Compliance Expert

    Vor 5 Tagen

    Stein, Schweiz Novartis Vollzeit

    766 million! That's how many patients' lives were touched by our products in 2021. At Novartis, we are reimagining medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many...

  • QA Manager 80-100%

    vor 1 Woche

    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...

  • CQV Professional – Lab and Facilities

    Vor 3 Tagen

    Stein, Schweiz Coopers Group AG Vollzeit

    CQV Professional – Lab and Facilities (CDMO)Are you a seasoned professional with extensive technical expertise in CQV? We are looking for CQV Engineers to join our client's team in Visp and Stein on a contract basis. The roles require a deep understanding of Qualification, Commissioning, and verification of both lab equipment and facilities.Key...

  • Process Expert

    vor 1 Woche

    Stein, Schweiz Novartis Vollzeit

    Over 799 million! - that's how many lives we reached with our products in 2021. And while we are proud of this, we continuously ask ourselves the question: how can we improve and extend even more lives in a world of digital and technological change? We are convinced that we can find answers if curious, courageous and team-oriented people are encouraged to...

  • Validation Expert

    Vor 5 Tagen

    Stein, Schweiz Novartis Vollzeit

    **Summary**: As a Validation Expert you will be executing process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. **About the Role**: **Key Responsibilities**: - Support Product...