Easter Seals Jobs

IT Business Process Analyst III

Date: Sep 17, 2024

Location:

Chennai, India, 600113

Company: Teva Pharmaceuticals

Job Id: 58273

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

How you’ll spend your day

• Exposure to Laboratory Application Software in a Pharma industry and it’s validation/qualification activities as per GAMP5 guidelines

• Understanding of documentation related to Quality processes such as Change Controls, CAPA, Deviations and Investigations.

• Expertise in System Development Life Cycle (SDLC) structure, Computerized Systems validations and Hardware Qualifications.

• Expertise in Application User Management, Back Up/Restore processes, Data Integrity Controls, Periodic Reviews, etc., as per GxP Compliance.

• Knowledge of GAMP5 and regulatory guidelines such as 21 CFR Part 11, EU Annex 11, etc.

• Exposure to Microsoft365 applications

• Vendor Management & Collaboration

• Knowledge of ERP System (preferably SAP) and first level support

Job Description Contd...

• Will work as an IT Partner for the Site GM & other Site Leadership team members

• Understanding the business processes with the business stakeholders and serving as IT Single Point of Contact for business applications Day-to-day Site activities associated with the IT operation of the site

• Participate, represent IT in all relevant meetings and support corporate initiatives and deliverable required.

• Establish and maintain effective relationships with external and internal stakeholders.

• Manage Stakeholders expectations, by communicating work performed and providing a follow-up plan if needed.

• Knowledge of computer maintenance and software installation & troubleshooting

• Ensure regulatory and operational requirements are maintained according to Teva standards and tools (i.e; 21 CFR Part 11 etc.).

• Technical Ownership of Site Application Systems

• Keeping all GxP Computerized Systems in Validated State, as per Regulatory Guidelines

• Act as a liaison between Site Quality Assurance, and other stakeholders to ensure compliance with applicable regulations, guidelines, and company procedures.

• Act as a Stakeholder Management business analyst resource for the global labs applications installed at the site.

• Enable user Access and supervise the user access management of the system to ensure that the system is accessible to authorized personnel only.

• Define/supervise auto Data Backup, Restoration Process and Disaster Recovery Plan to ensure that electronic data is secured and available as and when required.

• Initiating IT relevant Change Control / Deviations and Investigation & CAPA.

• Handling Regulatory Inspections (FDA, MHRA, TGA, and WHO) and client audit.

• Develop, implement, and maintain IT compliance policies and procedures.

• Plan, execute, and manage IT projects, ensuring those are completed on time and within budget.

• End User Support with regards to all Applications at site

• Implement / Roll Out Global Initiatives at site, in close collaboration with Global Project/Support teams

• Ensuring high levels of system and data availability

• Responsible for collaboration with all regional & global business and IT groups

Your experience and qualifications

• B.Sc. Computer Science / BCA / PGDCA / B.Tech. / B.E. (Computer Science/IT) Degree/Diploma in Management (Desirable)

• 6-10 Years

Reports To

Associate Director IT

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran