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- Aufgaben: Join us as a Validation Technician to ensure compliance and quality in our operations.
- Arbeitgeber: We are a leading pharmaceutical company committed to excellence and innovation.
- Mitarbeitervorteile: Enjoy a long-term temporary position with opportunities for growth and skill development.
- Warum dieser Job: Make an impact in the pharmaceutical industry while working with a collaborative team.
- Gewünschte Qualifikationen: A BS in Engineering or Technical discipline is required; experience in validation is a plus.
- Andere Informationen: This role involves coordinating with external vendors and internal departments.
Das voraussichtliche Gehalt liegt zwischen 42000 - 60000 € pro Jahr.
Job Summary: The Validation Technician, Validation Operation Services performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures. The Validation Technician is authorized to direct external vendors performing work in this field. Essential Job Functions: Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle. Author and when required review qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems. Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes. Participate to the development and maintenance of the local site procedures Participate to risk assessments and risk management teams Review change controls / NEF documents to evaluate impact on qualified systems and validated processes Develop and justify the validation approach based on risk and a scientific rational Co-ordinate qualification and validation execution activities, including external vendors and internal departments Experience / Education BS in Engineering or Technical discipline. Experienced in pharmaceutical qualification and validation; at a solid dosage plant is advantageous Knowledge / Skills / Abilities: Familiarity with current international regulatory regulations, cGxP requirements and best practises, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP Good communication skills in English with facility, production, laboratory, technical operations, QA, and outside vendor groups; French advantageous Team player: ability to interact effectively with team and customers
E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent ) Arbeitgeber: WuXi AppTec
Kontaktperson:
WuXi AppTec HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent )
✨Tip Number 1
Familiarize yourself with the specific cGMP regulations and guidelines mentioned in the job description. Understanding these regulations will not only help you during the interview but also demonstrate your commitment to compliance and quality assurance.
✨Tip Number 2
Highlight any experience you have with validation and qualification activities, especially in a pharmaceutical setting. Be prepared to discuss specific projects or tasks where you ensured compliance with local policies and procedures.
✨Tip Number 3
Showcase your ability to work collaboratively with external vendors and internal departments. Prepare examples of how you've successfully coordinated activities in past roles, as teamwork is emphasized in this position.
✨Tip Number 4
Brush up on your risk assessment skills. Be ready to discuss how you approach risk management and how you would justify validation approaches based on scientific rationale, as this is a key responsibility of the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent )
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the E-Validation Technician position. Understand the essential functions and required skills, as this will help you tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in pharmaceutical qualification and validation. Mention specific projects or tasks that align with the responsibilities outlined in the job description.
Showcase Technical Knowledge: Demonstrate your familiarity with cGMP regulations and international regulatory requirements. Include any relevant certifications or training that showcase your technical expertise in validation processes.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your enthusiasm for the role. Make sure to address how your skills can contribute to the company's success in maintaining compliance and quality.
Wie du dich auf ein Vorstellungsgespräch bei WuXi AppTec vorbereitest
✨Know Your Regulations
Familiarize yourself with cGMP regulations and international guidelines like 21 CFR part 11, 210, and 211. Being able to discuss these in detail will show your understanding of the compliance landscape.
✨Demonstrate Technical Knowledge
Be prepared to talk about your experience with validation and qualification activities. Highlight specific projects or tasks you've completed that align with the job description, especially in a pharmaceutical setting.
✨Showcase Your Communication Skills
Since the role requires interaction with various departments and external vendors, practice articulating your thoughts clearly. Prepare examples of how you've effectively communicated in past roles.
✨Emphasize Team Collaboration
This position values teamwork, so be ready to share experiences where you successfully collaborated with others. Discuss how you handle conflicts and ensure smooth operations within a team.
