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- Aufgaben: Support QA for CAPEX projects and ensure compliance with validation activities.
- Arbeitgeber: Join a leading pharmaceutical company based in the beautiful French part of Switzerland.
- Mitarbeitervorteile: Enjoy a 6-month contract with opportunities for professional growth and development.
- Warum dieser Job: Be part of innovative projects that impact global health while working in a collaborative environment.
- Gewünschte Qualifikationen: 5+ years in QA/QC, strong knowledge of cGMPs, and proficiency in English and French required.
- Andere Informationen: No motivational letter needed; just submit your CV and relevant documents!
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
For our client, a leading and innovative pharmaceutical company with its international headquarter based in the French part of Switzerland, we are searching for a:
Your main tasks
- Support CAPEX projects from a QA perspective
- Act as Quality Validation representative for site and global project implementations
- Provide quality and compliance support for validation activities associated with equipment qualification, Utilities qualification, Room qualification, and/or Computerized System Validation experience (CSV), cleaning validation, and/or process validation to ensure conformance to cGxPs, guidance documents, or applicable industry accepted standards
- Collaborate with project teams to resolve quality issues and organize QA activities
- Ensure effective communication among project stakeholders and within QA, implementing necessary processes
- Review and approve qualification/validation documents, including design specs, test plans, protocols, and reports
- Evaluate and approve deviations, incidents, and changes during equipment and systems qualification/validation
- Assist with drafting and reviewing procedural documents prepared by SMEs
- Promote compliance with data integrity and CSV requirements
- Participate in the site’s strategic Quality operations plan and support evaluation of change controls, deviations, and risk assessments
- Develop and implement training programs on production lines and associated processes for QA ops team
- Ensure EHS compliance and promote safe work practices
Your profile
- Minimum 5 years QA or QC experience in pharmaceuticals or regulated industries
- Strong knowledge of cGMPs, Swiss, EU, and FDA regulations, MES, and SAP
- Experience in qualification/validation of equipment/system or processes
- Proficient in Change Control, Deviation Management, and Risk Management
- Excellent analytical, communication, and interpersonal skills in French and English
- Works independently and effectively in cross-functional teams
- Strong problem-solving, risk mitigation, and critical thinking skills
- High sense of ethics, discretion, and diplomacy
- University degree in science preferred
- Proficient in English and French
Sebastian Pal is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary). Full discretion is guaranteed and we will gladly answer any additional questions.
AurigaVision AG
Herr Sebastian Pal
#J-18808-Ljbffr
QA Representative, Equipment Commissioning and Qualification (Ref. 2496) - 6 months contract Arbeitgeber: AurigaVision AG
Kontaktperson:
AurigaVision AG HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: QA Representative, Equipment Commissioning and Qualification (Ref. 2496) - 6 months contract
✨Tip Number 1
Make sure to highlight your experience with cGMPs and regulatory compliance in both your conversations and during interviews. This is crucial for a QA Representative role, as it demonstrates your understanding of the industry's standards.
✨Tip Number 2
Familiarize yourself with the specific CAPEX projects that the company has undertaken. Being able to discuss these projects and how you can contribute from a QA perspective will set you apart from other candidates.
✨Tip Number 3
Prepare to discuss your experience with validation activities, especially in relation to equipment qualification and Computerized System Validation (CSV). Providing concrete examples will showcase your expertise and problem-solving skills.
✨Tip Number 4
Since communication is key in this role, practice articulating complex QA concepts clearly and concisely in both French and English. This will demonstrate your strong interpersonal skills and ability to collaborate effectively with project teams.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: QA Representative, Equipment Commissioning and Qualification (Ref. 2496) - 6 months contract
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements for the QA Representative position. Tailor your application to highlight relevant experiences that align with these tasks.
Highlight Relevant Experience: In your CV, emphasize your minimum 5 years of QA or QC experience in pharmaceuticals or regulated industries. Include specific examples of your work with cGMPs, qualification/validation processes, and any relevant projects you've been involved in.
Language Proficiency: Since the role requires proficiency in both French and English, ensure that your application reflects your language skills. If applicable, mention any certifications or experiences that demonstrate your bilingual capabilities.
Prepare Your Documents: Gather all necessary documents such as your CV, diploma, and reference letters. Make sure they are up-to-date and formatted professionally. Remember, a motivational letter is not required for this application.
Wie du dich auf ein Vorstellungsgespräch bei AurigaVision AG vorbereitest
✨Showcase Your QA Experience
Make sure to highlight your minimum 5 years of QA or QC experience in pharmaceuticals or regulated industries. Be prepared to discuss specific projects where you supported CAPEX from a QA perspective and how you ensured compliance with cGMPs.
✨Demonstrate Knowledge of Regulations
Familiarize yourself with Swiss, EU, and FDA regulations, as well as industry standards related to equipment qualification and validation. During the interview, be ready to explain how you've applied this knowledge in past roles.
✨Communicate Effectively
Since excellent communication skills are crucial for this role, practice articulating your thoughts clearly in both French and English. Prepare to discuss how you've facilitated effective communication among project stakeholders in previous positions.
✨Prepare for Problem-Solving Scenarios
Expect questions that assess your problem-solving and critical thinking abilities. Think of examples where you successfully mitigated risks or resolved quality issues, and be ready to share these experiences during the interview.
