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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