SAP QM consultant
SAP QM Consultant Responsibilities: Support Central Quality processes and assist to enable robust and operational excellence at the respective site of responsibility. (Internal or External Manufacturing) Liaison between the site and the Central Quality organization Should have knowledge of GxP regulated processes to lead fit gap assessments against the Central harmonized processes and system application tools (e.g. SAP QM) Supports the execution and effectiveness of the SAP QM functions, including reporting and communications to Central Quality and Site Leadership Support site users to ensure integrity, consistency and compliance of site related processes with Central Quality process and application owners Provide trainings to site users about Key Performance Indicators and help in identifying opportunities for continuous improvement Support the SAP Mercury project Release 6.1 activities. This will include: Coordinate and potentially write / execute Unit, Integration and Fit for Use test scripts Provide oversight and back up support for the management of Quality owned Master data Must be able to help in writing standard operating procedures and aid in training documentation preparation The position requires compliance and regulatory knowledge to drive key decisions, Leadership/Change Management Skills to align organization/resources to a new process Consultant provides help in the following activities Creating, modifying, reviewing SOPs , test scripts, end user training materials, design and validation documents Partner with site and other Central Quality team leads to gather user requirements in relation to controlling and recording GxP activities Creating, modifying, reviewing, other compliance-related documents, for example: System / business change controls Assessment plans Risk assessments Non-conformance reports Corrective and preventative actions Audit reports Providing help in gathering data for regulatory inspections Requirements and Education: BS degree minimum A focused degree in a technical, scientific or related field is preferred 5 years in a highly automated manufacturing or pharmaceutical environment Experience in deploying and using SAP QM Knowledge in Computer system validation is mandatory Knowledge and experience working in Quality organization that includes External Manufacturing or plant start up functions is preferred Knowledge and experience with Cransoft master data workflow tools from Back Office Associates Knowledge and experience with other areas of SAP: MM, WM,IM, PM, and BW is preferred Must have a broad based knowledge and understanding of cGMP's and Quality Systems
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