What are the responsibilities and job description for the MES(Manufacturing Execution System) position at Cygtec Inc?
Job Details
Job Title: MES(Manufacturing Execution System) Resource
Location: Baltimore, Maryland, Onsite
Visa : Any
Job Description:
- Review and approve change controls in Trackwise, ensuring compliance with policies and regulatory standards.
- Conduct pre-approval, execution oversight, and post-approval of PQ protocols for SMP and MPR changes in TEMPO.
- Coordinate testing activities, resolve discrepancies, and document outcomes effectively.
- Draft and review final reports, including binder assembly of PQ protocols and associated documents.
- Lead process improvement discussions and update site SOPs to enhance efficiency and compliance.
- Author and review System Impact Assessment (SIA) and Data Integrity Assessments (DIA) for site applications.
- Collaborate with cross-functional teams for risk assessment and mitigation during change implementation.
- Ensure testing processes adhere to GMP and QMS standards while addressing deviations promptly.
- Maintain organized documentation for audits and regulatory inspections.
- Provide training and guidance on updated protocols and procedures to relevant stakeholders.
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