In this role, you will oversee cleaning operations, ensuring staff compliance and training, while collaborating with facility management and managing documentation and quality events related to cleaning.
Anforderungen
- •Preferred minimum 5 years experience in biotech or pharma
- •Facility Management and Project Management experience highly valuable
- •Extensive experience in writing GMP-documents
- •Deep understanding of cGMP
- •Strong interpersonal skills and collaboration ability
- •Fluent in speaking and writing German and English
Deine Aufgaben
- •Ensure GMP compliance in cleanroom cleaning.
- •Supervise cleaning staff of 35 personnel.
- •Provide ongoing training for cleaning staff.
- •Collaborate directly with Facility Managers.
- •Implement electronic documentation for cleaning activities.
- •Manage all cleaning-related GMP documents and quality events.
- •Serve as main SME for cleaning topics.
Original Beschreibung
# Facility Manager (temporary for 2 years)
**Basel** | **Full time**
##
### The Position
At the Basel Drug Substance Manufacturing site of F. Hoffmann-La Roche AG, you will gain a unique insight into the production of biologically active pharmaceutical ingredients for both commercial and clinical supply. The site operates through three value streams, Monoclonal Antibody (MAB), Antibody Drug Conjugate (ADC), and Single Use Technology (SUT), which are supported by five units (Process & Technology, Material Science & Support, Materials Management, Facilities Management & SHE, and Business Operations), along with Quality. Together, these teams focus on ensuring the reliable supply of medicines to patients.
We are looking for you as Facility Manager within the Facility Management Team (Unit Facilities Management & SHE).
### The Opportunity
* Ensure that the GMP-Compliance regarding environmental cleaning in cleanrooms is provided by the external service provider
* Supervise the cleaning staff (35 persons)
* Continuously ensure that all relevant trainings are provided to the cleaning staff
* Direct collaboration with Facility Managers of associated manufacturing buildings
* Implementation of an electronic documentation tool to track cleaning activities
* Main responsible for all cleaning related GMP Documents (SOPs, FORs etc. and Owner of any cleaning related Quality Events (Quality Incidents, Deviations, Changes, CAPA) in Veeva QMS
* Act as main SME for cleaning topics with customers and in regulatory inspections
### Who you are
You are working in a diverse environment and demonstrate flexibility, agility, and initiative. You possess the following qualifications:
* Preferred minimum of 5 year work experience in the biotechnical or pharmaceutical industry
* Facility Management and Project Management experience is highly valuable
* Extensive experience in writing GMP-documents
* Deep understanding of cGMP
* Strong interpersonal skills and the ability to collaborate effectively with various departments
* Fluent in speaking and writing German and English
##
**Roche is an Equal Opportunity Employer.**