Watson Pharma Hiring for validation Analyst Post

Recruitments for Watson Pharma Private Limited.2021. Hiring  for validation analyst posts. Full details are provided below.

Vacancy Details :

Name of the Company: Watson Pharma Private Limited.

Qualification: Bachelor’s degree in Lifesciences

Post Name: validation analyst

Experience : 5+ years

Job Location: Banglore

Vacancies: 01

Salary Package: NA

Contact No: NA

Post of date: 16/11/2021

Job Description: 

What you’ll do
  • 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:

  • Bachelor s 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.

Click here to Apply and for notification

About Company

Watson Pharmaceuticals  is a leading integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic, brand and biologic pharmaceutical products. Watson is among the top five pharmaceutical companies in the United States

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