QA Audit Management Specialist

Responsibilities

• Manage customer audits and regulatory inspections at the site
• Execute, prepare, and follow up on audits
• Maintain the global audit module in TrackWise
• Handle project tasks such as third-party audits and questionnaire creation
• Perform document reviews for global quality alerts and GMP documents
• Respond to customer inquiries and questionnaires
• Record and track key performance indicators (KPIs)

Requirements

• Degree in Chemistry, Pharmacy, Biology, or a related field
• Approximately 2 years of professional experience in a pharmaceutical environment (preferred)
• Extensive knowledge of GMP guidelines and application
• Knowledge of aseptic or sterile manufacturing and quality management (ideal)
• Strong communication, assertiveness, and diplomatic skills
• Structured and responsible way of working
• Fluent German and English skills

Benefits

• Fair tariff-based compensation including 13th-month salary and holiday pay
• Company pension scheme and additional nursing care insurance
• 30 days of vacation plus special leave
• 37.5-hour work week
• JobRad leasing and corporate benefits
• Modern on-site canteen with subsidies
• Relocation financial support
• Free company sports (Badminton, Football, Fitness courses)

About the Company

Simtra BioPharma Solutions is a premier CDMO that has been bringing sterile, injectable medicines to market for over 65 years, with a focus on cancer therapeutics.