Quality Systems Specialist - Royston - The O'Connor Group

Description

Job Type
Full-time
Description
Pharma Tech Industries is hiring a Quality Systems Specialist on-site in Royston, GA
The Quality Systems Specialist plays a key role in managing and maintaining core elements of the Quality Management System (QMS) and Supplier Quality to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. This individual is responsible for supporting the development, execution, and continuous improvement of quality system processes such as document control, change control, deviation management, CAPAs, Supplier Quality, Annual Product Reviews, Audits, and Quality Reports and Management Reviews. This position reports to the QA Manager.
Requirements

• Site subject matter expert (SME) on the eQMS document control system including contributing to the development and deployment of electronic Quality Management Systems (eQMS), including user acceptance testing and validation support.
• Support system upgrades, improvements, and QMS harmonization projects across sites or departments.
• Ensure timely initiation, review, escalation, and closure of quality system records including change controls, deviations, SCARs, CAPAs in accordance with regulatory and internal timelines.
• Manage the completion of Annual Product Reviews (APR) as specified within associated customer quality agreements and regulatory requirements.
• Collaborate cross-functionally with QA, QC, Manufacturing, Regulatory, and other departments to ensure consistent application and adherence to quality system procedures.
• Direct support of Supplier Quality, including associated onboarding activities/evaluations, maintenance of the approved supplier lists, and coordinating the associated site supplier audits per schedule.
• Analyze and report out on quality system trends and metrics to identify areas for improvement
• Support implementation of continuous improvement initiatives.
• Support of Site Internal Audits per schedule and follow up on associated corrective actions.
• Lead and assist in the performance of required periodic reviews of Quality SOPs and their revision, as necessary.
• Effectively communicate via oral and written methods with all departments and employees.
• Provide subject matter expert (SME) consult regarding the eQMS during internal, customer, and regulatory audits as required.
• Provide additional support for Quality Management as required.
• Assist in the preparation and hosting of regulatory inspections and audits; gather and provide documentation to auditors as needed.
• Create, revise, and maintain SOPs, work instructions, and quality system-related documentation.
• Ensure compliance with data integrity principles in all quality system activities.
• Provide training to personnel on the eQMS to ensure cGMP requirements are maintained.
• All other activities commensurate with the role, as required