Senior Integrity Specialist, GMP, Data Governance
Chalapathi Rao
Hello,
Please do have a look at the JD below and let me know if you are comfortable with the same or else, please do refer someone good for the same
Senior GMP, Data Governance & Integrity Specialist
Location : East Windsor, NJ 08520 – 100% Onsite
ESSENTIAL JOB FUNCTIONS:
· Oversees and manage data integrity and data governance programs for all operational information and automation systems across the site including Facility & Manufacturing Operations, Laboratory Operations, IT and QA Systems. Function as the site Quality Assurance SME in Data Integrity.
· Develops and maintain all site data management and governance procedures and assure compliance with applicable regulatory requirements. Assist and support all internal and external audits activities.
· Create data mapping processes and perform data process risk assessments of all GMP documentation systems. Identify data management gaps and enhance systems and procedures. Collaborate with cross-functional departments on identifying data integrity risks and implementing appropriate mitigations and/or risk controls. Lead change controls and/or complete data integrity impact assessments.
· Lead data integrity training program, train Operations, Laboratory Operations, IT and Quality personnel to achieve compliance on data integrity principles across the site.
· Track and monitor data integrity events across the site and escalate issues to senior leadership team. Leads data integrity investigations and implement appropriate CAPA actions.
· Provide SME support to all Quality area processes, including Quality Operations and Validation, as needed.
· Support the creation and execution of test protocols for IT, CSV and Data Integrity as needed for process improvement initiatives.
· Perform additional duties as assigned.
QUALIFICATIONS:
· Minimum of 12+ years of experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality laboratory operations, or IT.
· Bachelor’s degree in Science, Engineering or equivalent required;
· Strong attention to detail, ability to work collaboratively in a fast-paced environment, and a commitment to ensuring compliance with regulatory standards.
· Solid knowledge of FDA Data Integrity Guidance / requirements, FDA current Good Manufacturing Practices, and proficiency with Microsoft Office applications.
· Strong Knowledge of cGMP & GDP.
KEY COMPETENCIES:
Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
· Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
· Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
· Resourcefulness: Secures and deploys resources effectively and efficiently.
· Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
· Ensures Accountability: Holds self and other accountable to meet commitment.
· Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
· Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Thanks
Chalapathi Rao