The Process and GMP specialist coordinates compliance activities for the Supply chain department which includes timely management of deviations, CAPA plans and change controls within their area of expertise :
they manage the initiation of change controls and deviations for supply chain in the Trackwise system.
they drive Root Cause Analysis and defines Root Cause Counter Measures in close cooperation with team members.
they handle the execution and completion of defined CAPA’s within the team.
They will make sure that SOPs and Working Instructions remain up to date and are aligned with GMP and safety guidelines. They actively ensure adherence of the supply chain organization to general cGMP rules, Quality policies, procedures and instructions as rolled out by the Quality function and endorsed by the site management.
The candidate will also actively propose and lead continuous improvement initiatives for SAP processes by assisting with the implementation and qualification, raising the required Trackwise records and initiating change requests and workflows for the associated documentation.
The applicant :
Takes personal accountability for their presence, performance, and productivity for the achievements of defined objectives.
Thinks and acts with a customer-centric attitude.
Is intellectually curious and embraces Practical Process Improvement (PPI).
Removes barriers to success and enables a work environment where colleagues can be their best self and motivated to excel.
Thermo Fisher Scientific Inc. is an equal opportunity employer and is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance or an accommodation during the application process, please contact us at 1-855-471-2255. We value diversity and strive to create an inclusive and supportive work environment where all backgrounds and perspectives are respected.
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