Responsible for the establishment and ongoing compliance of processes related to Lot Disposition, Distribution, Post-Market Surveillance and Traceability Quality System Elements. Specifically, ensures systems and processes are properly implemented and maintained to appropriately disposition product once it is manufactured and maintain proper control and traceability of product through the storage and distribution processes. Supports Field Action and Customer Complaint activities by providing where-used and traceability records in addition to facilitating product return and containment where necessary.
Responsibilities: Essential Duties
- Responsible for product disposition process and activities, ensuring compliance to all quality and regulatory requirements.
- Responsible for QA oversight of distribution process, including product shipping, traceability, and containment. Requires collaboration with Distribution personnel to investigate discrepancies and ensure compliance to all quality and regulatory requirements.
- Responsible for traceability and containment (hold) of distributed product as required for discrepancy, complaint and field action handling. Requires collaboration with Compliance and Regulatory personnel to ensure compliance to all quality and regulatory requirements.
- Understands quality and regulatory requirements and integrates these within the company’s Quality Management System in accordance with system capabilities. Evaluates and implements system and process improvements to ensure that quality systems continue to meet regulatory requirements and expectations.
- Partners with Quality Operations on quality objectives related to quality systems and processes. Serves as a centralized team member for these initiatives. Ensures that user requirements are properly defined and documented, systems are structured to meet established requirements, and training is effectively provided to all affected personnel prior to implementation.
- Implements Corporate Operating Procedures and centralized processes and templates. Identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems are integrated.
Analyzes metrics and informatics to monitor the Quality System and its compliance. Identifies system and process issues, concerns or improvement opportunities and leads resolution.
Ensures that the Company’s Quality System policies and procedures are developed, implemented and maintained in compliance with regulatory requirements. Incorporates best practices while maintaining alignment to Company Objectives.
- Keeps informed of all existing and new regulatory requirements and works with Quality Operations to ensure full compliance in the Company’s Quality Systems.
Supports Company's affiliates on quality system and compliance matters, as required.
- Serves as a key quality systems expert to functional business units and Quality Operations.
- Travel to any Company and/or vendor facility, domestic and internationally, when necessary.
- Keep abreast of changes in the regulations, interpretation of the regulations and revising internal practices and written procedures to comply with the regulatory requirements.
Expertise: Knowledge & Skills
- Thorough knowledge of disposition and distribution requirements, quality policies and systems, FDA Regulations for pharmaceutical operations. Working knowledge of product inventory management system (SAP) desired.
- Strong working knowledge of all Quality System elements, such as CAPA, Risk Management and root cause investigation, document control, validation, design controls, and process controls.
- Must be able to work with all functional groups. Must demonstrate ability to work in a team setting to evaluate and resolve issues.
Ability to apply a broad knowledge of Quality Assurance principles, practices, and procedures to complex tasks.
Demonstrated skills in adaptability, team working, and interpersonal relationships are required in order to effectively perform this job function.
Strict attention to detail required. Problem detection ability a must.
Excellent written and verbal communication and interpersonal skills
- Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages.
Expertise: Qualifications - Experience/Training/Education/Etc
- Bachelor’s Degree required
- 4-8 years professional experience
- Minimum 4 years experience with FDA pharmaceutical requirements, cGMPs, and an ability to interpret regulatory requirements
- Experience with quality assurance standards such as ISO, ICH, USP & GxP