Project Leader, Quality Control

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Lonza

Consulting on the demand of the client in elaborated project plans (timing, phasing of approach, perform possible extra preliminary investigations, deliverables, organization of documentation and quality assurance).
Coordination of projects and taking care for the technical realization of project steps during method transfer and consulting on projects after method transfer
Reporting on project progress and addressing customer concerns and partner concerns when they arise. Gathering, analysing, and sharing project status updates and other relevant data as well at own initiative as on demand.
Partner with functional areas to ensure challenges or improvements are surfaced, managed, monitored/trended and escalated as required. Encourage seamless collaboration between clients, project members, and customers.
Initiation and completion of necessary process change controls, deviation and laboratory investigation reports. Creation, revision and review of cGMP documentation (SOP’s, Quality Instructions, protocols, reports…) based on a standard format related to quality control activities.
Responsible for providing and organizing adequate training to QC associates in order to enhance the site level compliance cGMP knowledge. Proactive follow-up on development activities within the applicable discipline as well building up and sharing of knowledge within the QC department.
Participate in project related audits.

MSc or PhD in Chemistry, Biology, or equivalent experience.
Proven analytical background (preferably with knowledge in HPLC, QC, and titration).
Familiarity with GMP regulations and standards is a plus.
Experience with LIMS, Empower, and Trackwise systems is an advantage.
Strong organizational skills with the ability to push back and be assertive when necessary.
Proficient in English; German language skills are a plus.

Don't forget to mention EuroPharmaJobs when applying.

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