Validation Expert

3 weeks ago

Boston, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Understand and able to review vendor Qualification document package in line with regulatory requirements.
  • Knowledge of System and Functional Risk assessment / management, defining risk mitigation plan.
  • Should have good Stakeholder management skills to interact with customer, business, and vendors efficiently.
  • Subject matter expertise in areas such as Quality Management, Document management, Software Development Life Cycle, Configuration Management and Change Management.
  • Should have good knowledge on Chromeleon LabVantage LIMS and Scitara, should have good understanding of Labvantage Scitara and Chromeleon integration works.
  • Should be able validate integration between two applications (Chromeleon and Scitara).
  • Should be able to author test scripts for Chromeleon and Scitara integration.
  • Review test scripts for Labvantage LIMS , Chromeleon, SoftMax , Scitara and Labx.
  • Know how on Equipment and Instrument qualification process and regulations.
  • Knowledge on Analytical lab instruments like CDS systems, Labx instruments and SoftMax plate reader.
  • Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security.
  • Ensure Compliance of Equipment in accordance to GxP regulations and customer QMS policies and procedures across Equipment Lifecycle.
  • Knowledge of various Validation tools and templates used throughout the pharmaceutical industry.
  • Knowledge and hands on experience conducting periodic review.
  • Knowledge on new regulations -Enable innovations, Quality by design, CSA.
  • Technical Writing Experience.
  • Basics of project leading skills
Requirements:
  • Excellent communication (oral and written) and attention to detail.
  • 8 to 10 years Lifesciences, should have analytical instrument and applications exposure.
  • bility to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
  • Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11.
  • Excellent knowledge of computer system validation and GAMP -5 standards.

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