You ensure quality oversight and compliance in production processes by collaborating with various functions to effectively manage investigations and support audits.
Anforderungen
- •University degree in life science or engineering
- •Minimum of 5 years in Quality Assurance
- •Practical experience in Commissioning & Qualification
- •Practical experience in Technical Change Control
- •Outstanding communication and teamwork skills
- •Excellent German and English language skills
- •Special experience in green field CAPEX projects
Deine Aufgaben
- •Oversee GMP-compliance for production assets.
- •Provide QA input for engineering projects.
- •Act as QA partner for equipment commissioning.
- •Review and approve SOPs and GMP records.
- •Coordinate complex deviation investigations.
- •Present topics during inspections and audits.
Original Beschreibung
# QA Manager Facility & Engineering
**Basel** | **Full time**
### The Position
Creating a future where we all have more time with the people we love.
As part of the local Quality Unit, the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team's responsibilities include the quality oversight of the qualification status of all production equipment, automation systems, laboratory equipment, the building infrastructure, the utilities, IT systems and OT systems of all four production areas on-site (large-scale production of monoclonal antibodies; medium-scale single-use technology for production of monoclonal antibodies; production of antibody-drug conjugates; production of synthetic molecules active substances).
### Your opportunity
* You have end-to-end quality oversight on the GMP-compliance status of all new & existing production assets in your assigned area of responsibility
* You provide QA input to assure GMP-compliance in engineering projects and equipment lifecycle activities
* You are the QA partner for various functions related to commissioning & qualification of production equipment and process automation, asset reliability & maintenance and calibration.
* You review and approve SOPs and GMP-records in the areas of Technical Change Control, Deviation Management and CAPAs.
* You coordinate and facilitate complex deviation investigations, root cause analyses and technical risk assessments.
* With your partners from various functions you present topics during health authority inspections and internal audits.
### Who you are
To successfully fill this role, you bring the following qualifications:
* University degree in life science or engineering
* Minimum of 5 years of experience in Quality Assurance at a biologics manufacturing site.
* Practical experience in Commissioning & Qualification of production equipment
* Practical experience in Technical Change Control, Deviation Management and CAPAs.
* Your collaboration with partners is characterized by outstanding communication and team work. You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements, analytical problem solving and scientific rationale.
* Excellent German and English language skills, both written and spoken.
* Any special experience and expertise is highly desirable: green field CAPEX projects, implementation of new production or automation technologies, zone concepts in biotech manufacturing, (matrix) people leadership, etc.
**Roche is an Equal Opportunity Employer.**