| Job Description: |
Must Have Technical/Functional Skills
· Expand the laboratory systems stack knowledge and understand local laboratory procedures.
· Support and configure laboratory equipment inside Empower and other systems to ensure correct
execution of laboratory testings.
· Accurately translate business processes into technical terms and vice versa
· Build and maintain awareness and knowledge of regulatory, legal, or quality requirements
impacting the quality control laboratory, and ensure that solution requirements comply
· Deliver and support laboratory systems stack to start up new quality control lab operations inside
the concord site.
· Work with global system teams to ensure operational readiness of laboratory systems to support
the operational objectives of the concord facility (i.e. validation plans, standard operating
procedures, training, etc.)
· Produce and maintain project and validation documentation
· Ensure systems remain in a validated state and manage their lifecycle through releases,
recapitalization, and retirement
· Ensure the incident, problem, configuration, and change/release management are all
accomplished in alignment with and understanding of business need
Roles & Responsibilities
· Prior work experience working in pharma or other GMP setting
· Strong working knowledge of quality control laboratory IDS systems (i.e. Empower, Lab Vantage,
etc.).
· Solid knowledge of Computer System Validation process · Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving skills · Effectively prioritize and escalate issues · Demonstrated learning agility and curiosity · Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions · Desire and ability to communicate using a variety of methods in diverse forums
Generic Managerial Skills, If any
· Resource should be quick learner and self-driven; capable of working with client partners to meet
strategic Objectives
· Resource must be able to identify, mentor and hone talent to build leaders from within a team
Desirable Skills:
Keyword:
Skills: EIS : Laboratory Information Management System (LIMS)
Experience Required: 4-6
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