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IT Applications Specialist

1 month ago

Riverview, United States Piramal Group Full time
Job Description

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
  • Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
  • Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
  • Identify and protect the original technical information as part of the company property.
Key responsibilities
  • Develop and implement Core Lab strategic narratives, aligning with cross-functional teams and leading Core Lab initiatives.
  • Install, configure, and optimize hardware, software, and communication links while ensuring minimal downtime. Diagnose, resolve, and document hardware and software problems in a timely and accurate fashion, and provide end user training and support as needed.
  • Maintain Active Directory and Group policies, deploy servers, patch management, Perform backups and server monitoring checks.
  • Support, Maintenance and User Administration of local Laboratory applications which will include Periodic System Reviews and System Audit Trail Reviews.
  • Provide front line support (level 1) to labs. Troubleshoot system errors and collaborate with vendor/global teams for resolution.
  • Act as main point of contact on site for Laboratory System Helpdesk which will include interacting with the Global system teams or system vendors on various system issues.
  • Providing appropriate system access to vendors.
  • Support system content deployment and end user training.
  • Recognizing the importance of the Quality control, Analytics and Process Development functions in pharmaceutical production, the IT Application and Lab Systems Specialist should display a high level of integrity in the performance of their work.
  • Take ownership of issues seeing it through from beginning to end.
  • Assist in deployment, monitoring, maintenance, data backup, documentation, upgrade, and support of all IT systems. This includes all servers, e-mail, PCs, phone systems, hardware, software, mobile devices, peripherals, switches, routers, cabling, and all associated operating systems and software.
  • Support LANs, WANs, Internet and Intranet Systems
  • Administration of GMP software as per regulatory requirements (21 CFR Part 11 and cGMP).
  • Receive and respond to help desk tickets, phone requests, and/or e-mails regarding IT issues.
  • Perform on-site analysis, diagnosis, and resolution of IT issues for a variety of end users and recommend and implement corrective hardware and software solutions.
  • Stays up to date with external best practices and the latest process and technology advancements in the field and uses this knowledge to develop and maintain role capability.
  • Prepare and ensure accuracy of documentation, end user binders, procedures, and manuals.
Qualifications

Education / Experience
  • Bachelor's degree in an IT or scientific field (e.g., Chemistry, Biology, Business Information Systems).
  • Minimum five (5) years' work-related experience.
  • Settled knowledge in Lab and QA systems such as labware LIMS, Agilent OpenLab CDS, Tiamo, TGA, XRPD, and/or similar systems in a GxP environment.
  • Business partnering and communication skills.
  • Service Management expertise
  • Working technical knowledge of VMware, backup software, databases, networks, servers, and PC operating systems.
Job Competencies
  • Ability to conduct research into networking issues and products as required; disseminate information as needed in a user-friendly language.
  • Knowledge of applicable data privacy practices and laws.
  • Strong problem-solving skills.
  • Excellent communication and interpersonal skills are essential.
  • Excellent organizational and prioritization skills
  • Ability to work well both independently and in a team environment.
  • Ability and flexibility to perform all other job-related and ad-hoc duties as required.
  • Able to multi-task and meet demands of customers.
  • Follow FDA, EPA, OSHA, GMP and 21 CFR Part 11 regulations.
  • Willing to work off-shift times, as necessary, to complete projects.