Management and maintenance of quality assurance activities by supporting operational departments in accordance with agreed timelines as well as global and local standards to ensure the GMP compliance within sterile manufacturing in Stein.
* Act as Quality single point of contact for the activities assigned
* Author, review and approve deliverables included but not limited to, such a SOPs, gap assessments, risk assessment, cleaning documents, WI)
* Coordinate, review and approve quality records included but not limited to, such as deviations, CAPAs, change controls, qualification and validation documentary) related to the manufacturing processes in Trackwise and KNEAT.
* Serve as QA oversight to ensure GMP compliance within manufacturing activities.
* Support SMEs during investigation, included but not limited, such as root cause analysis, impact assessment, action plan implementation.
* Participate in quality systems improvements projects and lead lean improvement projects to ensure efficiency in alignment with global and local standards
* Liaise with external partners/customers to set up a release strategy for deliverables in alignment with corporate standards as well as global and local standards
* Deliver expertise in all matters concerning cGMP compliance as required
* Define, manage and report Quality Key Performance Indicators (KPI), as needed.
* Execute, improve and maintain the Quality Oversight concept within DPS manufacturing.
* Provide QA support to Drug Product network of Lonza.
* Active participation in audits (internal and external) and inspections as needed per audit/inspection plan.
Key Responsibilities
* Participate and provide support to Growth Projects 41X operational departments in alignment with cGMP
* Monitor local and global meetings as well as project progress to ensure efficient and effective communication on project status
* Perform other agreed activities as assigned by the line manager.
* Support a culture of high performance and trust with all department.
* Onboard new members.
* Guide and support team members and peers in line with Lonza Values and Behaviors.
* Deputize Team Lead QA Operations – Growth Project as required.
Practicalities
Interested? Apply now or send CV to
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