KEY REQUIREMENTS:

• Master’s degree in chemistry, biotechnology, life science or related field.
• 5 years experience within the pharma industry
• Knowledge of GDP requirements and regulations would be preferred
• GDP or other relevant certifications would be a plus
• Familiarity with warehouse safety regulations and best practices
• Strong organizational and problem-solving abilities.
• Strong attention to quality
• Excellent verbal, written and interpersonal communications skills in English (German is a plus)
• Ability to align cross functional stakeholders to ensure GDP compliance
• Must interpret and maintain proficiency in regulations, standards, guidelines and trends in GDP
• Responds independently to most major issues but escalates all critical issues to supervisor
  Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
  People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
  

  LI-SG1

Reference: R60032
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ROLE PURPOSE:

Warehouse Quality compliance Manager to ensure quality oversight of Lonza Sales over respective warehouses.

KEY RESPONSIBILITIES:

• SOP Development and Implementation:
• Collaborate with cross-functional teams to set up Standard Operating Procedures (SOPs) for warehouse quality oversight.
• Create an SOP specifically addressing quality checks, inspections, and inventory accuracy.
• Ensure that all warehouse staff are trained on SOP compliance
• Ensure that products-related GMP activities that are delegated or contracted to other Lonza GROUP sites or third party contract sites by the RP are controlled through agreements and where appropriate audits.
• Ensure compliance to the conditions of the Wholesale Distribution Authorization and to evolving guidelines on Good Distribution Practice (GDP) as defined by the European Commission in OJ 2013/C 343/01 and Swiss Medic’s guidelines
• Ensure that products-related GDP activities that are delegated or contracted to other Lonza Sales AG sites or third party contract sites by the RP are controlled through agreements and where appropriate audits.
• Ensuring that a quality management system is implemented and maintained
• Ensure contribution to the implementation of a quality risk management system
• Ensure Product Review evaluation is performed in the area of responsibility
• Ensure participation and contribution in the Management Review in the area of responsibility
• Ensure inspection readiness for Lonza Sales AG.