Auf einen Blick
- Aufgaben: Lead the CQV team in pharmaceutical manufacturing, overseeing commissioning, qualification, and validation activities.
- Arbeitgeber: GXP Consulting Switzerland is a passionate team of Life Sciences professionals delivering industry expertise since 2014.
- Mitarbeitervorteile: Enjoy competitive salary, continuous learning opportunities, and a supportive team culture.
- Warum dieser Job: Join a diverse team where your leadership skills will shine and make a real impact in life sciences.
- Gewünschte Qualifikationen: BSc/MSc in Engineering or related field with 7+ years in commissioning and qualification activities required.
- Andere Informationen: Fluency in English is essential; German/French is a plus. Hands-on experience is valued.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
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We are looking for CQV – Commissioning, Qualification and Validation Leads and Managers
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry expertise and support to our clients in the complete range of product life cycle.
ABOUT THE ROLE:
- Lead the CQV team and oversee all commissioning, qualification, and validation activities within the pharmaceutical manufacturing facility.
- Develop and manage project plans, ensuring alignment with project timelines and budgetary constraints.
- Develop and implement CQV strategies that align with regulatory requirements and industry best practices.
- Direct the execution of commissioning protocols, qualification activities, and validation studies for equipment, systems, and facilities.
- Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ).
- Generation and execution of the system commissioning protocols, installation & operation qualification protocols, process qualification protocols.
- Identify the appropriate Commissioning and Qualification strategy.
- Schedule preparation and progress review.
- Execute some commissioning and qualification activities (hands-on experience).
If you have done most of the above in the past, and you possess exceptional Leadership and People Management skills we have the job for you.
ABOUT YOU:
- BSc/MSc Degree in Engineering, Bioengineering or any related field.
- 7+ years of experience in commissioning and qualification activities for pharmaceutical facilities.
- Experience in leading Commissioning and Qualification activities.
- Previous experience as leader of C&Q team.
- Strong knowledge and experience of Commissioning and Qualification.
- Knowledge in qualification & validation approaches (especially ASTM E2500) is highly relevant.
- Familiar with Kneat or equivalent.
- Excellent analytical, problem-solving, and decision-making abilities.
- Effective communication and interpersonal skills.
- Fluency in English is required. German/French would be a clear plus.
ABOUT US:
- We are a Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds.
- We do care about our people, communicate openly and value feedback.
- We work as a team where every member is valued and appreciated.
- We propose continuous learning and development opportunities via internal or external training and workshops.
- We offer a competitive salary package in line with industry practice together with exceptional employment benefits.
At GXP Consulting Switzerland, everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you!
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Project Management, and Production
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Operations Consulting
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CQV Lead - CQV Manager Arbeitgeber: Gxp Consulting Switzerland
Kontaktperson:
Gxp Consulting Switzerland HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: CQV Lead - CQV Manager
✨Tip Number 1
Make sure to highlight your leadership experience in CQV activities during networking events or informal meetups. Engaging with professionals in the pharmaceutical industry can help you gain insights and potentially get referrals.
✨Tip Number 2
Stay updated on the latest regulatory requirements and industry best practices related to commissioning and qualification. This knowledge will not only boost your confidence but also demonstrate your commitment to the field during discussions.
✨Tip Number 3
Consider joining relevant professional organizations or online forums where you can connect with other CQV professionals. These platforms often share job openings and can provide valuable advice on landing a role like this.
✨Tip Number 4
If you have experience with tools like Kneat, be prepared to discuss specific projects where you utilized these tools. Demonstrating hands-on experience can set you apart from other candidates.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: CQV Lead - CQV Manager
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the CQV Lead position. Understand the key responsibilities and required qualifications, as this will help you tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 7+ years of experience in commissioning and qualification activities. Provide specific examples of projects you've led or contributed to that align with the responsibilities outlined in the job description.
Showcase Leadership Skills: Since the role requires exceptional leadership and people management skills, include examples of how you've successfully led teams in the past. Mention any relevant training or workshops you've conducted to demonstrate your commitment to team development.
Tailor Your Application: Customize your cover letter to reflect your understanding of GXP Consulting Switzerland's values and culture. Mention how your personal values align with theirs and express your enthusiasm for contributing to their success.
Wie du dich auf ein Vorstellungsgespräch bei Gxp Consulting Switzerland vorbereitest
✨Showcase Your Leadership Skills
As a CQV Lead, demonstrating your leadership experience is crucial. Prepare examples of how you've successfully led teams in commissioning and qualification activities, highlighting your ability to manage diverse groups and drive projects to completion.
✨Understand Regulatory Requirements
Familiarize yourself with the regulatory landscape relevant to pharmaceutical manufacturing. Be ready to discuss how you have developed and implemented CQV strategies that align with these requirements and industry best practices.
✨Discuss Your Hands-On Experience
Since the role involves executing some commissioning and qualification activities, be prepared to share specific instances where you were directly involved in these processes. Highlight your practical knowledge of protocols like SAT, IQ, and OQ.
✨Communicate Effectively
Effective communication is key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex technical topics. Also, be ready to demonstrate your interpersonal skills, as collaboration with various stakeholders will be essential.