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- Tasks: Support and manage IT solutions in a fast-paced pharmaceutical lab environment.
- Company: Join a leading pharmaceutical company focused on innovation and quality.
- Benefits: Enjoy competitive pay, remote work options, and opportunities for professional growth.
- Why this job: Be part of a team that impacts healthcare through technology and collaboration.
- Qualifications: Bachelor's degree in relevant fields and 4+ years in validation or data integrity roles required.
- Other info: Experience with FDA regulations and SDLC methodologies is a plus.
The predicted salary is between 36000 - 60000 £ per year.
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Support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within Generics and Specialty areas of a Pharmaceutical laboratory environment which include but not limited to Chromatography Data Systems such as Empower, UV-Vis, GCMS etc.
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Support delivery of IT services and coordination with local, regional and global resources on the status of projects, service and support efforts.
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Collaborate with laboratory business, staff, IT colleagues, and other stakeholders to support existing processes and technologies. Identify customer requirements; assess impacts to the delivery of applications and other IT functions.
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Perform day-to-day system administration, maintenance & operational tasks for the Lab systems and ensures appropriate service levels are developed and monitored.
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Liaison with IT operational support teams for the peripheral equipment, such as servers, desktops, printers and storage devices.
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Involve in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
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Experience in providing face-to-face and remote end user support to laboratory users and applications in a highly regulated environment within the Pharmaceutical Industry.
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Perform PC/System specification configuration according to vendor requirements, works with IT Operations (ITO) for PC lab build, user group assignment and management, data backup setup and control, test data backup and restore, IQ/OQ test execution and documentation.
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Support with tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems. Ensures that system implementations are in keeping with the relevant FDA / 21 CFR Part 11, GxP guidelines as well as internal policies and processes.
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Ensure compliance with Data Integrity requirements and remediation activities for Laboratory systems
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Bachelor’s Degree preferably in Computer Science, Life Sciences, Information Systems Management, Computer Engineering, Electrical Engineering, or a related field or equivalent combination of relevant education and experience.
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4+ years working as a validation analyst / Data Integrity remediation activities
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4+ years working in regulated pharmaceutical companies
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Experience in 21 CFR Part 11, GAMP
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Experience in SDLC (Agile or Waterfall)
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5+ years working as a validation analyst / Data Integrity remediation activities
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5+ years working in regulated (GLP, GCP or GMP) biotech or pharmaceutical companies
IT Business Process Analyst II employer: Teva Pharmaceuticals
Contact Detail:
Teva Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IT Business Process Analyst II
✨Tip Number 1
Familiarize yourself with the specific Chromatography Data Systems mentioned in the job description, such as Empower and GCMS. Having hands-on experience or knowledge about these systems will give you a significant edge during discussions with our team.
✨Tip Number 2
Highlight your experience in regulated environments, especially within the pharmaceutical industry. Be prepared to discuss how you've ensured compliance with FDA regulations and GxP guidelines in your previous roles.
✨Tip Number 3
Showcase your collaboration skills by providing examples of how you've worked with cross-functional teams, including IT and laboratory staff. We value teamwork, so demonstrating your ability to communicate effectively with various stakeholders is crucial.
✨Tip Number 4
Prepare to discuss your experience with the Software Development Life Cycle (SDLC), particularly in Agile or Waterfall methodologies. Being able to articulate your role in past projects will help us understand your fit for this position.
We think you need these skills to ace IT Business Process Analyst II
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the IT Business Process Analyst II position. Understand the key responsibilities and required skills, especially those related to system administration, validation, and compliance in a pharmaceutical environment.
Highlight Relevant Experience: When writing your CV and cover letter, emphasize your experience in regulated pharmaceutical companies, particularly your work with validation activities and data integrity. Use specific examples that demonstrate your expertise in 21 CFR Part 11 and SDLC methodologies.
Tailor Your Application: Customize your application materials to reflect the language and requirements mentioned in the job description. Use keywords such as 'Chromatography Data Systems', 'Computer Systems Validation', and 'GxP guidelines' to align your application with the company's needs.
Showcase Collaboration Skills: Since the role involves collaboration with various stakeholders, include examples in your application that showcase your ability to work effectively with laboratory staff, IT colleagues, and other teams. Highlight any successful projects where you coordinated efforts across different groups.
How to prepare for a job interview at Teva Pharmaceuticals
✨Understand the Regulatory Environment
Make sure you are well-versed in the regulations that govern the pharmaceutical industry, especially 21 CFR Part 11 and GxP guidelines. Being able to discuss how these regulations impact IT processes will show your expertise and readiness for the role.
✨Showcase Your Technical Skills
Be prepared to discuss your experience with Chromatography Data Systems like Empower, UV-Vis, and GCMS. Highlight specific projects where you implemented or troubleshot these systems, as this will demonstrate your hands-on experience and problem-solving abilities.
✨Emphasize Collaboration
This role requires working closely with various stakeholders. Share examples of how you've successfully collaborated with laboratory staff, IT colleagues, and other teams to achieve project goals. This will illustrate your teamwork skills and ability to communicate effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your ability to handle real-world challenges in a regulated environment. Think of scenarios where you had to manage system administration tasks or ensure compliance with data integrity requirements, and be ready to explain your approach and outcomes.
