Quality Assurance ,Supply Chain Compliance Manager
Lonza
- Bâle
- Contrat
- Temps-plein
- Federal Act on Medicinal Products and Medical Devices (HMG SR 812.21)
- Medicinal Products Licensing Ordinance (AMBV SR 812.212.1)
- Ordinance on Medicinal Products (VAM SR 812.212.21)
- Good Distribution Practice of Medicinal Products for Human Use (2013/C 343(01))
- Falsified Medicines Directive (2011/62/EU)
- Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products from Switzerland (Swissmedic I-SMI.TI.18)
- Good Manufacturing Practice (Eudralex vol. 4) in line with oversight of licensed activities associated with contract manufacturing activities, as required per Swissmedic
- Oversee shipment validation processes to maintain product quality and safety
- Oversee the qualification of service providers
- Create / implement the temperature monitoring and transportation related incidents SOP.
- Assessment of transportation carrier routes and modes.
- Provide expertise in Regulatory Compliance for the products traded by Lonza Sales AG
- Ensure that products-related GMP 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.
- In depth knowledge of Good Distribution Practice requirements and regulations, experience in warehouse management is an asset
- 5+ years experience within pharma industry, preferably in a QA or GMP focused role
- GDP certificates or other relevant certifications is a plus
- Understanding of the cGMP regulations, especially GDP
- Strong organizational and problem-solving abilities.
- Ability to work autonomously with and to develop procedures if required
- Ability to oversee project execution to identify non-compliance from quality standards
- Excellent verbal, written and interpersonal communications skills in English (German is a plus)
- Ability to work in partnerships as an active member of a team and or/cross functional working groups
- Requires independent decision making regarding quality and compliance.