Quality Assurance, Warehouse Compliance Manager

Quality Assurance, Warehouse Compliance Manager

Lonza

Basel, Switzerland

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.

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

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