Compliance Expert

Job description

Job Description

Stein is a site of strategic importance for the manufacturing and launch of innovative medicine. One of the most important pharmaceutical production plants of Novartis Technical Operations is located in Stein: The plant Stein Steriles. The plant is launch site & center of excellence worldwide for innovative sterile drug products for injection containing Biologics as well as manufacturing site for clinical supplies of all sterile dosage forms required in global clinical studies.

The Compliance Expert plans and executes assigned GMP QA Compliance tasks related to the support of sterile manufacturing, such as: supporting qualification and validation activities related to routine manufacturing and launch projects, review and approval of GMP relevant documentation, change control, deviation handling and representation of QA Compliance Qualification & Validation in dedicated projects.

The main accountabilities are the following:

• Represent QA Compliance Qualification & Validation in relevant aspects e.g. in dedicated projects and commercial manufacturing
• Site QA Subject Matter Expert for CCIT and automated visual inspection.
• Review and approve process & cleaning validation protocols and reports (revalidation, verification, product transfers) including associated risk assessments and deviations
• Review and approve equipment, facility and utilities qualification protocols and reports including associated risk assessments and deviations
• Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
• Support inspections and audits (self-inspections, health authorities, customers etc.)
• Initiate, implement and support quality improvement projects and initiatives
• Train and onboard new members of the team
Position Title

Compliance Expert

Desired profile

Minimum requirements

• (Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent
• Post graduate diploma in business administration or equivalent
• Fluent in German and English (spoken and written)
• Professional experience in Quality Control / Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles / Biotechnology
• Profound knowledge of cGMPs
Job Type

Full Time
Country

Switzerland
Work Location

Stein (Säckingen)
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO QUALITY
Employment Type

Regular
Company/Legal Entity

Novartis Pharma AG