Our client is looking for a Data Integrity Specialist for their Exton PA offices.
- Serve as Data Integrity Leader within the Client's Biologics Pilot Plan Facility responsible for leading the implementation of the data integrity culture and strategy for the site and ensuring compliance with global and local regulatory requirements at the system level.
- Successfully carry out the Key Responsibilities in an organized manner in accordance with the priorities set forth by the site quality director.
- Focus on the fulfillment of site objectives and ensure the implementation of the corporate requirements of the Quality Management System.
- (Quality Management System) and regulatory requirements in relation to data governance, including the development of indicators that monitor the process and performance at the Site level.
- Generate communication and work plans with the different areas in order to ensure the Prevention and Detection of Data Integrity events, for example, through Implementation of Training Matrices, Communicate Good Data Integrity Practices and the implementation of related work tools.
- Coordinate the evaluation of new and existing systems (IT management systems, analytical and productive) with potential impact on product quality and generate mitigation plans for meet the requirements.
- Identify roles and responsibilities for the review, approval and execution of mitigation plans necessary to meet data integrity standards.
- Ensure the progress and compliance of the mitigation plans for electronic systems and documentation.
- Carry out internal inspections to ensure that the procedures associated with general guidelines for systems and documentation are in place.
- Lead the gap analysis of the policies associated with Data Integrity related to Good Documentation, Archiving and Retention of Documentation and Systems Practices electronic ensuring to keep local SOPs aligned to corporate requirements.
- Provide support in the event of internal, external and regulatory audits regarding the managing process.
- Maintain the Data Integrity status under a high level of control, performing assessments of the Quality Risk Model (QRM) on a three-monthly basis and generating action plans that ensure maintain high control and mitigate those points that are not within control, when apply.
- Establishment and leading an internal site network of DI champions and actively participating in multi-site DI Community of Practice
- Bachelor's Degree in Pharmacy, Biochemistry, Engineering or related field.
- At least 5 years of experience in the Pharmaceutical Industry in Quality Assurance areas or area related, including a position of authority in decision making and management of documentation and / or IT.
- Experience in the area of Validations, Quality, Engineering and / or any other functional area.
- Knowledge of Documentation and Electronic Systems that generate and manage GxP processes.
- Basic knowledge of Systems Operation and Good Documentation Practices and Data integrity.
- Knowledge in multiple quality processes and interfaces with multiple functional areas.
- Knowledge of Good Manufacturing Practices standards, and local regulatory requirements and international.
- Project management, organization and teamwork skills.
- Interpersonal and communication skills (teamwork, effective negotiation, resolution of problems, decision making, critical aptitude, ability to interact with personnel from other areas, other disciplines and with external personnel (technical advisers, system providers, consultants for systems, among others).
For more info on this & other exciting roles please contact me
MARC LEVINE C: 914-262-5142 E: firstname.lastname@example.org
PandoLogic. Keywords: Data Entry Clerk, Location: Immaculata, PA - 19345
Posting ID: 575437966Posted: 2020-09-27