GXP Validation Specialist

1 month ago

Pune, India KARYA CONSULTANTS PRIVATE LIMITED Full time

Key Responsibilities:

We are seeking a skilled Validation Engineer to join our team at KARYA CONSULTANTS PRIVATE LIMITED. As a key member of our team, you will be responsible for developing and implementing validation plans, protocols, and procedures that ensure compliance with regulatory requirements.

Key responsibilities include:

  • Developing and implementing validation plans, protocols, and procedures
  • Ensuring validation strategies align with project specifications and regulatory requirements
  • Drafting and reviewing validation protocols (IQ/OQ/PQ) and ensuring they meet industry standards and regulatory guidelines
  • Validating applications using SCADA/PLC systems, focusing on functionalities, performance, and compliance
  • Collecting, analyzing, and reporting validation test data
  • Maintaining thorough documentation, including validation protocols and summary reports
  • Ensuring compliance with regulations such as GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards
  • Collaborating with teams like Quality Assurance, Engineering, and Production to ensure alignment of validation activities
  • Identifying process improvement opportunities in validation activities
  • Proposing and implementing Corrective and Preventive Actions (CAPA)

Required Skills and Qualifications:

To be successful in this role, you will need:

  • Bachelor's degree in Engineering, Computer Science, Information Systems, or related fields
  • Certification in Validation Engineering or Quality Management is a plus
  • 3-4 years of experience in Validation Engineering, with a focus on software validation, PLC/SCADA systems, and regulatory compliance
  • Experience with System Development Life Cycle (SDLC) and GAMP 5 guidelines

Regulatory Knowledge:

You will need to have:

  • Familiarity with FDA 21 CFR Part 11, GxP, and Good Documentation Practices (GDP)
  • Understanding of ISO standards and Good Automated Manufacturing Practices (GAMP)

Technical Skills (Software-Related):

You will need to have:

  • Proficiency in validating and managing SCADA (Supervisory Control and Data Acquisition) and PLC (Programmable Logic Controller) systems
  • Experience in SQL to handle database validation and support data queries for validation purposes
  • Familiarity with tools for automated testing and validation within SCADA/PLC environments
  • Experience with software like HP ALM, JIRA, or other similar tools for managing validation tasks, defect tracking, and reporting
  • Understanding of ladder logic diagrams and ability to download and modify PLC/HMI application programs
  • Familiarity with tools for ensuring compliance with 21 CFR Part 11 and other regulatory standards

Other Skills:

You will need to have:

  • Strong understanding of validation processes for Computer Systems (CSV) and PLC/SCADA systems
  • Ability to read and understand wiring and ladder logic diagrams for PLC/SCADA systems
  • Experience with SQL for database validation and querying
  • Proficiency with test management tools for logging and tracking defects during validation (e.g., HP ALM, JIRA, or other similar tools)
  • Experience preparing and executing documents such as GAP analysis, IRA, FRA, FDS, FMEA, SRS, and Validation Summary Reports (VSR)

This role primarily applies in industries such as pharmaceuticals, biotechnology, medical devices, automotive, or manufacturing, where ensuring compliance with strict regulatory standards is crucial for quality and operational safety.

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