Responsible for the establishment and ongoing compliance of processes related to Manufacturing Controls, Packaging and Labeling, and Incoming Inspection Quality System Elements. Responsible for the master batch record and supporting master data within the Quality System Elements. Ensures systems and processes are properly implemented and maintained for compliant execution and documentation of batch manufacture controls, incoming material controls, and product/material traceability.
Responsibilities: Essential Duties
- Responsible for establishing and maintaining the electronic batch record within the Manufacturing Execution System. Requires collaboration with Automation Engineering and Operations personnel to ensure compliance to all quality and regulatory requirements.
- Responsible for QA review of MES recipes and workflows, ensuring compliance to process, quality and regulatory requirements.
- Responsible for maintaining Quality master data for materials and inspection plans within SAP. Requires collaboration with Quality Control and Operations personnel to ensure compliance to all quality and regulatory requirements.
- Responsible for maintaining Quality master data within all existing data systems, as applicable, such as the Label Management System and Inventory Management System.
- Analyzes existing systems to improve upon vertical and horizontal system interfaces and efficiencies.
- Investigates and resolves system problems.
- 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 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 batch record requirements, quality policies and systems, FDA Regulations for pharmaceutical operations. Working knowledge of electronic batch record and MES systems 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.
Bachelor’s degree required
4-8 years professional experience
Minimum 4 years experience with FDA requirements, cGMPs, and an ability to interpret regulatory requirements
Experience with quality assurance standards such as ISO, ICH, USP & GxP
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.