the delivery of project in collaboration with internal and external stakeholders. Responsibilities Act as Project SME regarding technical aspects Drive project risk analysis Propose CAPAand Deviation actions Support the Basic and Detail design, FAT, installation, commissioning/SAT and qualification (PQ) Ensures implementation of divisional and corporate procedures andmore »
D in Basel Support of implementation of DI requirements Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (correctiveactionandpreventiveaction), Risk Analysis Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements more »
for project activities Offering process support for engineering, qualification, and validation of new equipment Providing ongoing technical support for change control, deviation investigations, andCAPA management Your experience/knowledge: Experience in executing static and dynamic Site Acceptance Testing SAT, Performance Qualification PQ, and ensuring compliance with cGMP and company more »
defined and applied within the business. • Coordination and leadership of reported quality/technical issues from business teams and customers, ensuring that appropriate correctiveandpreventiveaction is taken by the accountable function through use of multifunctional team activities and that the originator of the issue is informed. • To perform … To conduct investigations to assess the probable root cause of any deficiency noted during process confirmation activities, informing the accountable function, and ensuring correctiveandpreventiveaction is taken. • Compile and Present Quality overview to the leadership team within the business area Required Skillset: • Ability to interpret drawings. • Ability to more »