A leading global pharmaceutical company is expanding their QA team as they build a brand new production site near Hamburg, Germany.
Key responsibilities of the QA Manager:
GMP-compliant qualification and validation (data integrity / software validation)
Oversee the quality of new projects (e.g. new systems, new products, validation activities)
First point of contact for technology, production, quality control, the warehouse for quality-relevant events and GMP issues
Carry out the review of manufacturing documentation and manufacturing instructions
Evaluate deviations, carry out root cause analyzes and risk assessments and define appropriate corrective measures
Coordinate quality-related matters with the Global Quality Assurance team
Requirements:
Several years of professional experience in the field of manufacturing sterile dosage forms in a comparable position
Very good GMP knowledge of international regulations
Experienced in the introduction and follow-up of CAPA measures
High degree of assertiveness and very good communication skills
Very good command of written and spoken English and German
Benefits:
Competitive salary paid out across 13 months
Performance-based bonus model
Extensive training and development opportunities
Secondary benefits (vacation pay, capital formation benefits, company pension scheme)