What are the responsibilities and job description for the MES(Manufacturing Execution System) Resource position at Cygtec Inc?
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.
Send a copy of your resume and your contact details to rshaik@linxai.com so that we can communicate
NOTE : Need Passport number and LinkedIn ID and please do mention Current Location and Visa of candidate while sending the Profile.