Job Description

Data Integrity Specialist needed in Exton – 3372

BB3372 Exton, PA 19341 12+ Months

$32.50

As a Data Integrity Champion, you will serve as Data Integrity Leader within the Client 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.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• (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

Basic Qualifications We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s Degree in Pharmacy, Biochemistry, Engineering or related field. • At least 3 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.

Preferred Qualifications If you have the following characteristics, it would be a plus:

• 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).

As Client Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk. • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. • Continuously looking for opportunities to learn, build skills and share learning. • Sustaining energy and well-being. • Building strong relationships and collaboration, honest and open conversations. • Budgeting and cost-consciousness.