QA EBR Lead

Sharp Packaging Services•Allentown, PA

18h

About The Position

SUMMARY: The QA Electronic Batch Record (EBR) Lead will be responsible for leading the implementation, validation, and ongoing maintenance of the Manufacturing Execution System (MES) and support applicable EBR systems within GMP operations. This role ensures the EBR system is compliant and efficient batch execution, documentation, and review. Serves as Subject-Matter-Expert (SME) between Quality, Operations, Validation and IT. Supports integration and validation features/functionality with other enterprise software systems. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to the QA EBR Lead position. Other duties may also be assigned.

Requirements

Experience in inspection of pharmaceutical or related industry and knowledge of FDA regulations related to cGMP’s is required.
Good written and oral communication skills are required.
Good organizational and planning skills are required.
Able to communicate and interact effectively with others
Strong understanding of manufacturing processes, especially in regulated industries like pharmaceuticals.
Knowledge of GMP and other relevant regulatory requirements.
Proficiency in data management and analysis.
Excellent communication, collaboration, and problem-solving skills.
Ability to train and support users on new systems.
Experience with electronic signatures and audit trails.

Nice To Haves

Thorough knowledge of quality control/assurance and/or operations is preferred.
Experience with MES systems preferred.
Experience with ERP systems.

Responsibilities

Lead cross-functional implementation of MES/EBR across warehouse, production, and quality operations.
Develop and execute system qualification deliverables in accordance with 21 CFR Part 11, EU Annex 11 and applicable regulation/standards to maintain data integrity.
Provide QA oversight for configuration management, user access controls, and periodic system reviews.
Conduct impact assessments and QA oversight during system configuration updates, upgrades, or patches to ensure continued validated state.
Work with cross-functional teams to manage change controls, deviations, CAPAs, and periodic system reviews.
Author, review, and maintain SOPs, Work Instructions, Validations Protocols and Risk Assessments for EBR processes.
Support the integration of EBR functionality with related systems such as ERP, LIMS and QMS.
Assist in establishing and maintaining a periodic internal audit program to verify ongoing compliance with data integrity and system validation expectations.
Serve as QA system owner and technical SME for EBR, functionality, configuration and compliance.
Lead comprehensive training programs for QA, Operations and supporting departments on EBR usage, data integrity, and GMP documentation requirements.
Define, track and trend key performance indicators (KPIs) for EBR performance.
Ensure adequate data is collected and trended for analysis during Management Review and Annual Product Review.
Lead and participate in continuous improvement to enhance compliance and efficiency of the EBR system and ancillary processes.
Participate in internal, regulatory and customer audits at the discretion of management.