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Quality Systems Specialist - ERP 10/10/2017

Bachem Torrance, CA

Company
Bachem
Location
Torrance, CA
AJE Ref #
579723577
Job Classification
Full Time
Job Type
Regular
Company Ref #
372860
Experience
Entry Level (0 - 2 years)

JOB DESCRIPTION

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The ERP Quality Systems Specialist will oversee the quality assurance aspects of implementing SAP at two manufacturing sites in the US. This Quality Assurance cross-functional role ensures that all relevant business processes in the US, which may have an impact on GMP compliance, meet the expected regulatory standards. This individual will work directly with the global SAP project team and local team members in the US to ensure quality relevant processes at the US sites are compliant with cGMP regulations. The incumbent is responsible to ensure GMP Operations deliverables for the US sites fall within the applicable timeline and scope. He/she is responsible for smooth implementation of end-to-end quality relevant processes. This position will be responsible for managing US implementation of future phases of SAP that will be adding more functionality in the coming years from the GMP Operations standpoint. This position will work closely with all functional areas in the US that are involved with SAP implementation of quality relevant processes to ensure the hand-off between different areas is carried out properly. The incumbent will be responsible for approving Quality relevant SAP documents.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Represents the US Quality Assurance Department in the global SAP project
Single point of contact for all US QA-related concerns
Provides regular updates to the project manager
Identifies and raises area specific bottlenecks and resource issues for the US sites
Participates in workshops, trainings and relevant project meetings
Evaluates impact of the SAP implementation on GMP relevant processes and resources and makes recommendations for optimal outcome to senior management
Ensures QA/QC deliverables for the US sites are completed within the global project timelines
Coordinates activities of QA and QC departments in the US to meet the global project demands
Coordinates and monitors document revisions at US sites to meet the project goal
Ensures end-to-end quality processes are compliant with US FDA and other regulatory agencies requirements
Establishes and manages communication channels with the global and local management team
Approves Quality relevant changes in material master data
Monitors the validation activities in the context of the new CSV guideline for software validations
Approves functional specifications and user requirement specifications
Approves computer system validation documents