QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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CSV Engineer to upgrade a Raised Stopper Detection (RSD) System, which inspects vial stopper placement prior to crimping. Additionally, the resource will implement a new SCADA System to virtualize applications across and starting with their RSD and Trayloader systems.

Responsibilities

• Develop System Requirement Documents for Raised Stopper Detection System (RSD) and a SCADA System.
• Ensure compliance with their guidelines for validation at the assigned site and their system requirements.
• Manage up to three document revisions.
• Coordinate reviews and approvals with designated representatives.
• Perform their documents management system (request document numbers, upload, route for reviews and approvals).
• Deliver final documentation including: Original unprotected electronic files (MS Office format) and scanned copies of approved documents (PDF format).

• Background in pharmaceutical products manufacturing environment, especially in sterile packaging.
• Experience in Commissioning and Qualification.
• Strong knowledge of cGMP regulations.
• 5+ years of experience in Computer System Validation.
• Excellent skills in writing validation/commissioning and technical documentation in English using MS Office applications.
• Bilingual (English and Spanish).

Preferred Skills

• Familiarity with Syntegon applications and their legacy system upgrades.
• Experience with virtualization technologies.
• Understanding of FDA and GMP compliance.

All your information will be kept confidential according to EEO guidelines.