Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summary:
Provide technical support and quality assurance oversight to maintain compliance with GMP standards. Support functions which include, but are not limited to, documentation review, instrument qualification/validation, equipment calibration, process monitoring, APQR Quality System, Data Integrity and, computer system validation.
Functions:
Apply technical knowledge to address a broad range of issues to ensure adherence to and compliance with established policies and procedures, as well as requirements of applicable regulatory agencies by working along side one or more of the following areas: manufacturing, testing, quality systems (SOPs, QRs, etc.), qualification-validation and data integrity.
Provide QA support to resolve environmental and system issues.
Assist in writing and revising site SOPs or other procedures.
Provide Quality oversight for qualification/validation and monitoring programs. Review and approve qualification and validation documentation. Collaborate with departments to ensure validation activities are performed efficiently.
Troubleshoot and resolve resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Participate in the design and implementation of department and cross-functional initiatives.
Train personnel and internal customers on relevant business processes. Provide guidance and coaching to internal customers in the application of GMP throughout Quality.
Review technical/investigation reports as appropriate.
Participate on cross-functional project teams to provide open communication to Project Management on implementation-related operational issues and site standards associated with projects.
Interface closely with other cross-functional groups such as Quality Control, Quality Assurance, MSAT, Operations, Engineering and, Project Management, to define and/or verify the scope of work for a particular project.
Review protocols, procedures, and training documentation to ensure compliance with current regulations and best methodologies for the project implementation.
Lead and / or support detailed investigations of project-related quality issues (CAPA's, Deviations, Audit Observations, protocols, etc.), ensuring effective corrective and / or preventive actions occur.
Present, facilitate, and lead process improvement and PPI activities in Quality Assurance.
Maintain a state of inspection readiness.
Participate in self inspection, client, and regulatory audits.
Other Duties if required.
Education:
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