Senior Qa Expert Manufacturing Release 80-100% (M/F/D) Jetzt bewerben
Senior Qa Expert Manufacturing Release 80-100% (M/F/D)

Senior Qa Expert Manufacturing Release 80-100% (M/F/D)

Gränichen Vollzeit 80000 - 120000 € / Jahr (geschätzt)
Jetzt bewerben
Lonza

Auf einen Blick

  • Aufgaben: Lead quality oversight in sterile drug manufacturing and ensure compliance with GMP standards.
  • Arbeitgeber: Join Lonza, a global leader in life sciences dedicated to improving lives through innovative solutions.
  • Mitarbeitervorteile: Enjoy a collaborative work environment with opportunities for career ownership and personal growth.
  • Warum dieser Job: Be part of a team that tackles real-world challenges in patient treatment and makes a difference.
  • Gewünschte Qualifikationen: Requires a Master's degree and 7-10 years in Quality Assurance within the pharmaceutical industry.
  • Andere Informationen: Fluency in English is essential; German is a plus. Engage in meaningful projects that impact millions.

Das voraussichtliche Gehalt liegt zwischen 80000 - 120000 € pro Jahr.

Switzerland, Stein 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.Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers 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 the position as a Senior QA Expert Manufacturing Release for supporting our new sterile Drug Product facility in Stein.Key responsibilities:Quality Oversight at DPS Manufacturing, including but not limited to, aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques Author, review and approval of GMP documents (e.G. batch records, SOPs) Review and approve protocols and reports e.G., APS, holding time studies, cleaning studies, equipment/room qualification as applicable Review and approve change requests, deviations and CAPAs related to product and process Facilitate the execution of deviation review boards Provide support to Sterile Production Stein line functions in GMP compliance related issues in area of expertise Lead or co-lead continuous improvement and innovation projects within quality operations Lead or co-lead campaign preparation readiness and PPQ batches Represent QA Operations in inspections, audits and local and global initiatives Participate in self-inspections, GEMA walks and audits as required Perform other duties as assigned Deputy of Team Lead QA Operations-Growth Project as required Key requirements:University or academic degree (e.G. Masters) in Chemistry, Biology, Pharmacy or equivalent At least 7-10 years of professional experience in Quality Assurance and/or Quality Control in a manufacturing environment within the pharmaceutical Industry, preferably in Sterile manufacturing of drug products Possess in-depth knowledge of Good Manufacturing Practice (GMP); sterile drug product aseptic manufacturing, Annex I regulations and ICH guidelines Experience in Swissmedic inspections, FDA inspections, and other health authorities is desired Possess strong project management skills, problem solving skills and ability to work autonomously Customer-oriented mindset and collaboration with internal and external stakeholders Ability to handle ambiguity and complexity of Growth Projects is a plus Fluency in English (spoken and written) is a must. Fluency in 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: R59178

Senior Qa Expert Manufacturing Release 80-100% (M/F/D) Arbeitgeber: Lonza

At Lonza, located in the picturesque Stein, Switzerland, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through continuous learning opportunities and the chance to lead impactful projects in the life sciences sector. Join us to not only advance your career but also contribute to meaningful solutions that improve lives globally.
Lonza

Kontaktperson:

Lonza HR Team

StudySmarter Bewerbungstipps 🤫

So bekommst du den Job: Senior Qa Expert Manufacturing Release 80-100% (M/F/D)

✨Tip Number 1

Familiarize yourself with the specific regulations and guidelines related to GMP and sterile manufacturing. Understanding Annex I regulations and ICH guidelines will not only boost your confidence but also demonstrate your commitment to quality assurance in the pharmaceutical industry.

✨Tip Number 2

Leverage your network to connect with current or former employees at Lonza. Engaging in conversations about their experiences can provide you with valuable insights into the company culture and expectations, which can be beneficial during interviews.

✨Tip Number 3

Prepare to discuss your experience with inspections from Swissmedic, FDA, and other health authorities. Highlighting your familiarity with these processes will showcase your expertise and readiness for the role of Senior QA Expert.

✨Tip Number 4

Demonstrate your project management skills by preparing examples of past projects where you led continuous improvement initiatives. This will illustrate your ability to handle complex challenges and contribute positively to the team at Lonza.

Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Qa Expert Manufacturing Release 80-100% (M/F/D)

Good Manufacturing Practice (GMP)
Aseptic Manufacturing Techniques
Quality Assurance and Quality Control
Regulatory Compliance (Swissmedic, FDA)
Project Management
Problem-Solving Skills
Change Management
Deviation Management
Continuous Improvement Methodologies
Environmental Sampling
Technical Writing (SOPs, Batch Records)
Collaboration with Stakeholders
Fluency in English (spoken and written)
Fluency in German (advantage)
Ability to Handle Ambiguity and Complexity

Tipps für deine Bewerbung 🫡

Understand the Role: Make sure to thoroughly read the job description for the Senior QA Expert position. Understand the key responsibilities and requirements, especially the importance of GMP knowledge and experience in sterile manufacturing.

Tailor Your CV: Customize your CV to highlight relevant experience in Quality Assurance and Quality Control within the pharmaceutical industry. Emphasize your knowledge of GMP and any specific projects that align with the role's requirements.

Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for quality assurance and your ability to contribute to Lonza's mission. Mention specific experiences that demonstrate your problem-solving skills and project management capabilities.

Highlight Language Skills: Since fluency in English is a must and German is an advantage, make sure to clearly state your language proficiency in your application. This can set you apart from other candidates.

Wie du dich auf ein Vorstellungsgespräch bei Lonza vorbereitest

✨Understand GMP and Aseptic Techniques

Make sure you have a solid grasp of Good Manufacturing Practices (GMP) and aseptic manufacturing processes. Be prepared to discuss your experience with these concepts, as they are crucial for the role.

✨Showcase Your Problem-Solving Skills

Prepare examples from your past work where you successfully navigated complex issues or led continuous improvement projects. Highlight your project management skills and how you've collaborated with stakeholders.

✨Familiarize Yourself with Regulatory Standards

Brush up on relevant regulations such as Annex I and ICH guidelines. Being knowledgeable about Swissmedic and FDA inspections will demonstrate your expertise and readiness for the role.

✨Communicate Effectively in English and German

Since fluency in English is a must and German is an advantage, practice articulating your thoughts clearly in both languages. This will help you connect better with the interviewers and show your adaptability.

Senior Qa Expert Manufacturing Release 80-100% (M/F/D)
Lonza Jetzt bewerben
Lonza
  • Senior Qa Expert Manufacturing Release 80-100% (M/F/D)

    Gränichen
    Vollzeit
    80000 - 120000 € / Jahr (geschätzt)
    Jetzt bewerben

    Bewerbungsfrist: 2026-12-14

  • Lonza

    Lonza

    5000 - 10000
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