Quality IT Systems Lead
Location: Near Sellersville, PA
The individual in this role will be responsible for overseeing and guiding Quality projects at the site. As the Quality IT Systems Lead, they will act as a bridge between the site and the corporate quality management team, specifically in the area of Information Systems. Their main tasks will include identifying and resolving computer-related quality issues at the site, fostering communication within the site, and providing training as needed. They will actively seek opportunities to enhance the site's Quality IT/IS and computer automation workflows. Additionally, they will support the implementation of the computer validation strategy at the site and share insights from the IT & Quality Corporate group to ensure consistency.
Responsibilities
• Conduct quality review and approval (Quality signatory) of all regulatory site-based computer system documentation in accordance with SOPs.
• Provide oversight to ensure consistent adherence to Policies, Procedures, Standards, Guidelines, etc. pertaining to computer system development, operation, and maintenance.
• Coordinate compliance audits of documentation repositories at the site level.
• Perform in-process audits of deliverables for projects according to Piramal SOPs.
• Develop and maintain site repositories for computer validation and maintenance documentation.
• Offer expert consultation and guidance for Quality IT and computer system projects at the site. The coordinator should possess the ability to effectively communicate regulatory requirements (e.g., 21CFR Part 11) and regulatory terminology to customers and system owners in a manner that is both comprehensible and relevant.
• Deliver support for computer system projects, lending assistance as needed.
• Contribute to the evaluation of necessary project resources and the development of project schedules.
• Supervise external contractors engaged in providing automation services for specific projects, as necessary.
• Aid in the formulation of cost estimates for Quality IS projects at the site, when requested.
• Formulate and monitor project schedules for Quality IS projects at the site, overseeing the entire process from initiation to completion.
• Revise and establish Standard Operating Procedures (SOPs) tailored to specific IT systems at the site, ensuring adherence to compliance requirements such as CSV (Computer System Validation), periodic review, audit trail review, backup/restore procedures, etc.
• Develop a validation strategy and review validation deliverables for Quality Control (QC) and Manufacturing systems, such as PLC/SCADA, GC, HPLC, etc.
• Provide support to the Corporate Quality and Compliance (QeC) team for site-specific projects implemented by the Corporate IT team, including systems like Trackwise, Ensure, LMS, SAP, etc.
• Collaborate with the Site Data Integrity Compliance Officer (DICO) and IT Single Point of Contact (SPOC) to ensure data integrity compliance for IT systems.
• Investigate incidents, deviations, or data integrity issues related to IT systems, and establish Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) accordingly.
• Conduct training sessions and raise awareness among site teams regarding CSV and IT compliance requirements and processes.
• Participate in Governance meetings to stay updated on IT developments and collaborate with the Corporate QeC team to ensure adherence to corporate standards and guidelines.
• Perform periodic reviews and audit trail examinations of IT systems at the site to assess compliance with SOPs.
• Handle front-end client and regulatory audits pertaining to CSV and IT compliance, addressing any observations, and ensuring compliance.
Qualifications
• Bachelor’s degree in chemistry or a related scientific field.
• Minimum of 3 years of laboratory experience.
• Proficient in the following areas: quality practices and processes, metrics development, project management, automated system validation, data integrity, security, electronic records, and electronic signatures within a regulated environment. Knowledge of automated systems, particularly pharmaceutical automation systems, is a plus.
• Familiarity with the current industry expectations for validation requirements in software and equipment validation/qualification.
• Technical proficiency in problem-solving and troubleshooting equipment systems in a pharmaceutical setting.
• Ability to make challenging decisions and drive them to completion, even in the face of resistance and unexpected obstacles.
• Positive attitude towards changes in the work environment and a commitment to continuous improvement.
• Experience in training analysts and a dedication to supporting their professional growth.
• Strong computer skills, including proficiency in MS Office.
For more information or immediate consideration send resume to lisabarrett@scientificsearch.com, job#17924
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