Beschreibung

In this role, you will oversee quality assurance for GCP, PV, and GLP activities, ensuring compliance and continuous improvement. Your daily responsibilities will include managing audits, training, and non-conformance issues while supporting inspection readiness.

Anforderungen

• •University degree in pharmacy, chemistry, or equivalent
• •Minimum 10 years of experience in the Pharmaceutical industry
• •Minimum 5 years of experience in QA GCP
• •Excellent knowledge of GCP and PV legislation
• •Experience in auditing GCP, PV, and GLP
• •Experience in GCP/GVP related Health Authority Inspections
• •Familiarity with writing/reviewing regulatory documents
• •Ability to work independently and collaboratively
• •Well-organized and structured
• •Excellent technical and analytical skills
• •Excellent communication and presentation skills
• •Fluency in English written and spoken
• •Any other language would be beneficial

Aufgaben

• •Provide QA oversight for GCP, PV, and GLP activities
• •Act as QA contact for vendors and investigator sites
• •Support continuous improvement of the Quality Management System
• •Establish and update QMS documents
• •Contribute to a risk-based strategy for QA activities
• •Manage non-conformances related to GCP, PV, and GLP deviations
• •Oversee quality issues, investigations, CAPAs, and change control
• •Ensure inspection readiness for Basilea and vendors
• •Review audit findings and generate CAPAs
• •Conduct training for GCP, PV, and GLP activities
• •Prepare for and follow up on audits and inspections
• •Track, record, and report audit results
• •Coordinate and lead internal and external training activities

Benefits