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- Aufgaben: Lead quality records and support change control processes in a dynamic team.
- Arbeitgeber: Join Lonza, a global leader in life sciences making a real impact on people's lives.
- Mitarbeitervorteile: Enjoy career ownership, creative problem-solving, and the satisfaction of improving lives worldwide.
- Warum dieser Job: Be part of a culture that values ethical success and continuous improvement in quality management.
- Gewünschte Qualifikationen: Bachelor or Master in life sciences with significant GMP experience; knowledge of quality standards is a plus.
- Andere Informationen: English proficiency required; German is a bonus. Work permit may be needed for non-citizens.
Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.
Social network you want to login/join with: Senior QA, Change Control Specialist (m/f/d), Visp Client: Location: Job Category: Other Job Reference: 78af58f862a0 Job Views: 9 Posted: 21.01.2025 Expiry Date: 07.03.2025 Job Description: Today, Lonza is a global leader in life sciences operating across three continents. 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. As a member of the QA Projects and Change Controls group in BioAtrium, the Change Control Specialist (f/m/d) supports in QMS GMP compliance (e.g. hosting CCRB, supporting raising and closure of changes), promotes the adherence and continuous improvement of Quality Systems and ensures Quality oversight in the specified area. Key Responsibilities: Own quality records such as change controls, CAPAs, investigations, effectiveness checks in line with valid SOPs. Lead the Change Control Review Board (CCRB) and CAPA Review Board (CRB) as required. Host change control clinics to support Production, MSAT, validation, CQV and other Quality members with change controls. Author, review and approve GMP-relevant documents and SOPs in the ownership of QA. Support and participate in internal, customer and regulatory audits. Electronic batch record: recipe review and approval. Support continuous improvement programs to establish effective Quality Management Systems. Key Requirements: Bachelor or Master Degree in life sciences (e.g. chemistry, biotechnology or a related field). Significant work experience in the GMP-regulated industry; preferably in the following units: Production, QC or QA, Operations. Broad knowledge in Quality standards (e.g. ICH Q7, 21 CFR Part 11). Knowledge of electronic systems such as Delta V, Syncade, SAP, LIMS, Trackwise is an advantage. English language skills (written and spoken) are required, German is an advantage. Every day, Lonza’s products and services have a positive impact on millions of people. 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. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information. Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the \’Apply now\‘ button. #J-18808-Ljbffr
Senior QA, Change Control Specialist (m/f/d) Arbeitgeber: Whatjobs
Kontaktperson:
Whatjobs HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior QA, Change Control Specialist (m/f/d)
✨Tip Number 1
Familiarize yourself with the specific Quality Management Systems (QMS) and GMP compliance standards mentioned in the job description. Understanding ICH Q7 and 21 CFR Part 11 will give you a solid foundation to discuss your relevant experience during the interview.
✨Tip Number 2
Highlight any experience you have leading or participating in Change Control Review Boards (CCRB) or Corrective and Preventive Action (CAPA) processes. Be prepared to share examples of how you've successfully managed quality records and improvements in past roles.
✨Tip Number 3
If you have experience with electronic systems like Delta V, Syncade, or SAP, make sure to mention it. These skills are advantageous for this role, and demonstrating your proficiency can set you apart from other candidates.
✨Tip Number 4
Since English is required and German is an advantage, practice discussing your qualifications and experiences in both languages. This will not only prepare you for the interview but also show your commitment to effective communication in a diverse workplace.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior QA, Change Control Specialist (m/f/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Senior QA, Change Control Specialist position. Tailor your application to highlight relevant experiences in GMP compliance and quality management systems.
Highlight Relevant Experience: Emphasize your significant work experience in the GMP-regulated industry, particularly in Production, QC, or QA. Provide specific examples of how you've contributed to quality oversight and continuous improvement in previous roles.
Showcase Your Skills: Mention your knowledge of quality standards like ICH Q7 and 21 CFR Part 11, as well as any experience with electronic systems such as Delta V, Syncade, SAP, LIMS, or Trackwise. This will demonstrate your technical proficiency and suitability for the role.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the job description. Explain why you're passionate about working at Lonza and how your skills can contribute to their mission of improving lives through life sciences.
Wie du dich auf ein Vorstellungsgespräch bei Whatjobs vorbereitest
✨Understand GMP Compliance
Make sure you have a solid grasp of Good Manufacturing Practices (GMP) and how they apply to the role. Be prepared to discuss your experience with quality management systems and how you've ensured compliance in previous positions.
✨Familiarize Yourself with Quality Standards
Review key quality standards such as ICH Q7 and 21 CFR Part 11. Being able to articulate your understanding of these regulations will demonstrate your expertise and readiness for the role.
✨Showcase Your Leadership Skills
As a Change Control Specialist, you'll be leading review boards. Prepare examples of how you've successfully led teams or projects in the past, particularly in a GMP-regulated environment.
✨Prepare for Technical Questions
Expect technical questions related to electronic systems like Delta V, Syncade, and SAP. Brush up on your knowledge of these systems and be ready to discuss how you've used them in your work.
