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- Aufgaben: Supervise compliance and manage QA activities for Drug Product Visp.
- Arbeitgeber: Join Real Staffing, a leader in the pharmaceutical industry.
- Mitarbeitervorteile: Full-time position with opportunities for growth and development.
- Warum dieser Job: Be part of a dynamic team improving drug quality and customer satisfaction.
- Gewünschte Qualifikationen: 5-10 years in pharma/biotech; strong QA knowledge required.
- Andere Informationen: Fluency in English is essential; German is a plus.
Das voraussichtliche Gehalt liegt zwischen 36000 - 60000 € pro Jahr.
Sales Consultant at Real Staffing – SThree
QA PL Drug Product Specialist
Duration: 8 months initial
Tasks:
- Supervise compliance and customer Quality Agreement (QAA) activities for Drug Product Visp.
- Establish and negotiate QAAs with Drug Product Services (DPS) and Drug Substance (DS) sites.
- Address QA-related questions, topics, and complaints from customers.
- Manage changes, deviations, technical complaints, and out-of-specification results.
- Represent QA in cross-functional teams and customer meetings during technical transfers.
- Act as QA contact for specific projects and manage routine follow-ups with customers.
- Support and approve project/product-specific risk assessments and regulatory gap assessments.
- Review and release product-specific documentation.
- Collaborate with QC-Project Leader (QC-PL) and MSAT for new product introductions (NPI).
- Assess, review, and approve quality records, including deviations, change control, CAPAs, and investigations.
- Author, review, and approve GMP-relevant documents and SOPs.
- Support continuous improvement programs for the Quality Management System.
Requirements:
- 5-10 years of experience in pharmaceutical or biotechnology industries.
- Strong QA and Quality Management Systems knowledge.
- Experience in establishing and negotiating QAAs.
- Ability to manage customer interactions and handle complaints.
- Understanding of risk assessments and regulatory requirements.
- Excellent communication and teamwork skills.
- Experience with GMP-relevant documents and SOPs.
- Ability to support continuous improvement programs.
- Fluency in English; proficiency in German is a plus.
- Proficiency in handling deviations, change control, CAPAs, and investigations.
- Collaboration with QC-Project Leaders and MSAT for new product introductions.
- Valid Swiss work permit or EU-Citizenship.
Seniority Level: Entry level
Employment Type: Full-time
Job Function: Quality Assurance
Industries: Pharmaceutical Manufacturing
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QA PL Drug Product Arbeitgeber: Real Staffing
Kontaktperson:
Real Staffing HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: QA PL Drug Product
✨Tip Number 1
Make sure to familiarize yourself with the specific Quality Agreement activities and compliance requirements in the pharmaceutical industry. Understanding these nuances will help you stand out during interviews.
✨Tip Number 2
Highlight your experience in managing customer interactions and handling complaints. Be prepared to discuss specific examples where you've successfully navigated challenging situations.
✨Tip Number 3
Demonstrate your knowledge of risk assessments and regulatory requirements by staying updated on current industry standards. This will show your commitment to quality assurance and continuous improvement.
✨Tip Number 4
If you have experience with GMP-relevant documents and SOPs, be ready to discuss this in detail. Sharing your insights on how you've contributed to quality management systems can make a strong impression.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: QA PL Drug Product
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the QA PL Drug Product position. Understand the key responsibilities and requirements, especially regarding compliance, customer interactions, and quality management systems.
Tailor Your CV: Customize your CV to highlight relevant experience in pharmaceutical or biotechnology industries. Emphasize your knowledge of QA processes, your ability to manage customer complaints, and any experience with GMP-relevant documents.
Craft a Strong Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the role. Mention specific experiences that align with the tasks listed, such as negotiating Quality Agreements or managing deviations.
Highlight Communication Skills: Since excellent communication and teamwork skills are crucial for this role, provide examples in your application that demonstrate your ability to collaborate effectively with cross-functional teams and manage customer interactions.
Wie du dich auf ein Vorstellungsgespräch bei Real Staffing vorbereitest
✨Understand Quality Agreements
Make sure you have a solid grasp of Quality Agreements (QAAs) and be prepared to discuss your experience in establishing and negotiating them. Highlight any specific examples where you've successfully managed these agreements.
✨Showcase Your QA Knowledge
Demonstrate your understanding of Quality Management Systems and how they apply to the pharmaceutical industry. Be ready to talk about your experience with GMP-relevant documents and SOPs, as this will be crucial for the role.
✨Prepare for Customer Interaction Scenarios
Since managing customer interactions is key, think of examples where you've handled complaints or QA-related questions effectively. This will show your ability to maintain strong relationships with clients.
✨Emphasize Team Collaboration
Collaboration is essential in this role, so prepare to discuss your experience working in cross-functional teams. Share specific instances where your teamwork led to successful project outcomes, especially in technical transfers.
