You collaborate with various teams to ensure compliance and quality in qualification activities, enhancing standards and managing inspections effectively.
Anforderungen
- •Bachelor's or Master's degree in Engineering
- •Minimum 5 years experience in Pharma manufacturing
- •Proficiency in multicultural project teams
- •Excellent organization and planning skills
- •Excellent writing and communication skills
- •Proficiency in English, German knowledge preferable
Deine Aufgaben
- •Oversee GMP aspects of qualification activities with cross-functional teams.
- •Ensure compliance with cGMP regulatory expectations during qualifications.
- •Review and approve qualification activities per GMP standards.
- •Assess and address qualification issues with multiple departments.
- •Continuously improve quality standards for quality systems.
- •Review and approve documentation for quality systems compliance.
- •Support inspections and drive closure of identified gaps.
- •Enhance knowledge management and continuous improvement processes.
Deine Vorteile
Multifaceted job opportunity
Integrity-driven company culture
Comprehensive induction training
Opportunity to impact success
Original Beschreibung
# Senior Quality Assurance Qualification Specialist
**Lengnau, Switzerland** | **Full time** | **Fully Onsite**
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
We are seeking a highly qualified **Senior Quality Assurance Qualification Specialist** to join our diverse team in Lengnau. As a global leader in scientific research and innovation, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are looking for a daring individual with confirmed experience in Pharma manufacturing site and a strong background in Engineering or Life Sciences.
**Key Responsibilities:**
* Work closely with cross-functional teams to oversee GMP aspects of qualification activities, ensuring the delivery of outstanding facilities, utilities, and equipment.
* Ensure compliance with cGMP regulatory expectations during qualification activities.
* Review and approve qualification activities in accordance with GMP standards.
* Assess and lead issues related to qualification, working closely with Manufacturing, QC, Engineering, and other relevant departments.
* Continuously improve quality standards for assigned quality systems and manufacturing areas.
* Review and approve quality systems-related documentation, ensuring compliant manufacturing of pharmaceutical products.
* Support internal and external inspections and drive the closure of identified gaps.
* Further active knowledge management and drive continuous improvement processes within the department.
**Your Qualifications:**
* Bachelor's or Master's degree in Engineering or Life Sciences (Biology, Chemistry, etc.), or equivalent.
* min 5 years Experience in Pharma manufacturing site.
* Proficiency in working with multicultural and cross-disciplinary project teams
* Excellent organization, planning, problem solving and critical thinking skills
* Excellent writing, communication, and presentation skills
* Language: Proficiency in English, German knowledge preferable
**We offer** a multifaceted job in a dynamic and international environment. A culture in which you live integrity, intensity, involvement, and innovation. A well-founded induction and task-specific training are a matter of course for us. You yourself resolve your future in our company – make your contribution to joint success!
As an employer, Thermo Fisher Scientific is committed to equal opportunity and cultural minority support and does not discriminate based on ethnic origin, colour, religion, gender, sexual orientation, gender identity, national origin, disability, or legally protected status.