QA Launch Manager

For our client in STEIN we are looking for a QA LAUNCH MANAGER for a 6-MONTH PROJECT.

DURATION: 2017-12-01 BIS 2018-06-30

LOCATION: STEIN

WORKLOAD: 100%

JOB PURPOSE:
Manage QA/QC transfers and launches projects.

Reporting line to the QA/QC Head Quality Business planning, Launches and Transfers

MAIN TASKS:
. Steering of assigned projects regarding time, resources, quality and costs.
. Accurate and timely reporting and communication of status and relevant KPIs to site management
. Ensure alignment of the different QA/QC projects with the site Strategy and input into Site Master Plan.
. Manage from QA/QC perspective Drug Product related launches and transfers activities in collaboration with QA compliance Qualification & Validation, QA compliance Quality System, QA Operation, QC and QA for QC (Matrix leadership).
. Ensures that the quality of the documentation is adequately completed for all New Product Introductions, Launch and Transfer.
. Participate to the project teams and liaise efficiently within the site and outside.
. Define and monitor projects key milestones and timing
. Assure that all activities are performed according to current processes and standards (GMP, HSE, Regulatory)
. Proactively provide information on current Regulatory and Novartis Quality Standards, expectations and requirements as applicable for each of the projects.

MINIMAL REQUIREMENTS:
. Minimum 5 year's experience in the pharma industry including QA and or Production experience.
. Good understanding of validation, process validation and product launches related processes.
. Fluent in German and English (spoken and written)

For further information please contact Beata Arciszewska:

(see below)