Validation Expert - Boston, United States - Katalyst Healthcares and Life Sciences

Katalyst Healthcares and Life Sciences Boston, United States

3 weeks ago

Description

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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