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Skills: System Validation, pharmaceutical/medical devices environment, VMP, VSR, and IQ/OQ/PQ protocols, knowledge of regulations and guidelines (21 CFR Part 11, 211, 820, and Annex 11), QA

Experience level: Associate Experience required: 3 Years Education level: Bachelors degree

Job Function: Engineering Industry: Logistics and Supply Chain Total position: 3

This role is contract-to-hire and offers a hybrid work model!

Job Summary/Description

This QA Computer System Validation Supervisor provides guidance to the company Solutions (SCS) Information Technology (IT) department to maintain the validation of warehouse or support systems utilized for healthcare applications. This role assesses systems being evaluated for use in healthcare applications and provides training and subject matter expertise to achieve/maintain validated status. The incumbent identifies systems requiring validation, escalates validation issues appropriately, and provides validation expertise. This position manages validation documents, determines applicable regulations, and reviews and approves testing of changes to validated systems.

The incumbent consults with internal groups (e.g., Operations, Business Development, IT, etc.) investigates and resolves healthcare issues to ensure compliance with rules and regulations. This position writes and revises Standard Operating Procedures (SOPs) and work instructions to ensure proper procedures are followed by Operations, IT, or Order-to-Cash personnel. This role participates in information gathering and scheduling to prepare for internal and client audits. The incumbent assesses current SCS capabilities to determine SCS's ability to meet client requirements and proposed solutions. This position develops and revises change control procedures, training, and audits to ensure validation maintenance.

Requirements

JOB DUTIES

• Writes, executes, and reviews validation protocols, generates validation reports, and performs corrective actions for deviations to provide subject matter expertise for SCS in validation matters
• Reviews policies, procedures, and regulations with internal/external clients to determine specialized requirements and ensure compliance
• Coordinates document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data are maintained in an orderly manner and meet quality standards
• Leads validation personnel or projects, when assigned
• Records information and observations from internal audits to support the preparation and distribution of internal audit reports
• Establishes and maintains quality policies and programs within the IT area to ensure proper documentation and data control methods are utilized
• Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities
• Interacts with internal auditors to discuss audit plans and findings
• Ensures continued learning of new/existing regulatory requirements by the various regulatory bodies governing our healthcare industries
• Participates in consultations with Corporate Legal to determine compliance implications of pending business
• Ensures consistent and timely completion of compliance-base tasks as assigned including but not limited to NCs, CAPAs, Audit findings, and Document Changes/Management
• Follows up with clients after audits to identify issues and mutually acceptable solutions

Minimum Requirements

• Bachelor's Degree (or internationally comparable degree) in Computer Science, Information Systems, or related field Preferred
• Possesses knowledge of Supply Chain Logistics
• Experience in the Healthcare industry
• Minimum of 3 years of computer system validation in a pharmaceutical/medical devices environment, including thorough knowledge of regulations and guidelines (21 CFR Part 11, 211, 820, and Annex 11), experience writing VMP, VSR, and IQ/OQ/PQ protocols, and SDLC methodologies (GAMP)?

MUST HAVE

Minimum of 3 years of computer system validation in a pharmaceutical/medical devices environment, including thorough knowledge of regulations and guidelines (21 CFR Part 11, 211, 820, and Annex 11), experience writing VMP, VSR, and IQ/OQ/PQ protocols, and SDLC methodologies (GAMP).

Possesses knowledge of Supply Chain logistics.

Experience in the Healthcare industry.