Teva Pharmaceutical Industries ltd Looking for IT Business Process Analyst III at Bengaluru, Karnataka Full Time

Hands on experience in Pharmaceutical laboratory environment for evaluation and validation of computerized systems per GAMP5, 21 CFR Part11.

Leads and supports implementation of life cycle methodology (Concept, Planning, Design, Testing, Operation, and Retirement) and assess Computerized Systems based on criticality and complexity.

Authors, reviews, approves, executes (as applicable) computer system validation documents per SDLC – Risk Assessments, Validation Plans & Reports, User requirements, Functional & Design specifications, Qualification Protocols/Test Scripts (IQ, OQ, PQ, UAT), Trace Matrix etc.

Develop standardized implementation practices around data management within a cloud environment.

Participate in all aspects of Cloud solution delivery life cycle including analysis, design, development, testing, production deployment and support.

Candidate must have experience with validation of Laboratory applications namely, but not limited to, High Pressure Liquid Chromatograph, Gas Chromatograph, FTIR, UV-Visible Spectrophotometer, Atomic Absorption Spectrometer, Karl Fischer Titrator, Liquid Chromatograph Mass Spectrometer, Softmax, Watson LIMS, Fusion, Labware LIMS, Empower, Electronic Lab Notebook etc.

Ensures IT solutions are compliant with the appropriate regulations, Data Integrity requirements and TEVA standards governing computer systems through the entire lifecycle.

Contributes to SOP revisions, Periodic Reviews, change controls, vendor audit, audit trail reviews, impact analysis.

Experienced in training business unit for the creation / execution of the automation scripts.

Be able to understand and perform PC/System specification configuration according to vendor requirements, , user group assignment and management, data backup setup and control, test data backup and restore, IQ/OQ test execution and documentation.

Strong understanding of underlying technical framework from an Operating System, infrastructure, database, backup, networking perspective.

Remotely support other Teva sites across multiple time zones as needed in a highly regulated environment within the Pharmaceutical Industry.

Knowledge of the use of EDMS, Trackwise, ALM (Application Lifecycle Management) a plus.

Excellent verbal and written English communication skills.

Qualifications

Education Required:
Bachelors Degree preferably in Computer Science, Life Sciences, Information Systems Management, or a related field or equivalent combination of relevant education and experience.

Experience Required:
5 years working as a validation analyst / Data Integrity remediation activities

5 years working in regulated pharmaceutical companies

Experience in 21 CFR Part 11, GAMP

Experience in SDLC (Agile or Waterfall)

Experience Preferred:
7 years working as a validation analyst / Data Integrity remediation activities

7 years working in regulated (GLP, GCP or GMP) biotech or pharmaceutical companies

Experience in 21 CFR Part 11, GAMP

Experience in SDLC (Agile or Waterfall)

Company/Industry Related Knowledge:
Experience working in a highly regulated environment within the Pharmaceutical Industry.

Knowledge and experience of cGMP and its implementation to laboratory instrumentation and laboratory processes.

Education: Any Graduate

Industry: Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial

Skills Required

information technology information systems management computer system validation life cycle alm

Job Detail

Job Id

JD2527254

Industry

Not mentioned

Total Positions

1

Job Type:
Full Time

Salary:
Not mentioned

Employment Status

Permanent

Job Location

Bengaluru/ Bangalore (Karnataka),

Education

Not mentioned

Experience

7 to 10 Years