IN
Job Description
Key Responsibilities:
- Minimum of 14 years in the Life Sciences sector with expertise in CSV Validation for GxP systems
- Act as a subject matter expert in Quality Engineering practices related to IT systems and solutions, including:
- Clinical Trial Management Systems such as Veeva CTMS, Medidata Rave, Oracle Siebel
- Regulatory Platforms including Veeva Vault RIM and Veeva Vault
- Laboratory Information Management Systems (LIMS) like LabVantage, LabWare, and STAR LIMS
- Supply Chain management tools like Kinaxis
- In-depth knowledge of essential pharmaceutical regulations, including 21 CFR Part 11, EU Annex 11, CSA, 21 CFR Part 820, and GAMP5 principles
- Understanding compliance with FDA, EMA, ICH, and other regulatory frameworks relevant to Life Sciences
- Engage in business development efforts, including proposal creation, solution demonstrations, and client workshops
- Proficiency in utilizing test management tools such as ALM, qTest, and JIRA
- Extensive hands-on experience with the lifecycle of CSV and CSA deliverables, which includes:
- a
- Validation Plan
- b
- Requirements Specification (URS) and Functional Requirements Specification (FRS) analysis
- c
- Risk assessment methodologies
- d
- Creation, updates, and execution of Val IQ, OQ, and PQ test cases
- Familiarity with Valgenesis or Kneat is considered a plus
- Knowledge of cloud technologies such as AWS and Azure, along with data standards like GDPR and HL7, and an understanding of cybersecurity in regulated environments
- Excellent communication and interpersonal abilities
- Capability to work autonomously as well as collaboratively within cross-functional teams is preferred
Technical Requirements:
- PROJECT MANAGEMENT, LIMS Testing, GxP Testing