What are the responsibilities and job description for the Instrument Validation Consultant position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description
Responsibilities :
- Plan, execute, and document validation activities for laboratory and manufacturing instruments, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop and review validation master plans, protocols, and reports.
- Perform gap assessments and requalification for legacy systems.
- Ensure compliance with applicable regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, ICH guidelines, and ISO standards.
- Work closely with QA, manufacturing, and R&D teams to resolve compliance gaps.
- Documentation :
- Create and maintain validation documentation, including SOPs, work instructions, and user requirements specifications (URS).
- Prepare risk assessments and traceability matrices to demonstrate validation coverage.
- Validate a variety of instruments such as HPLC, GC, spectrophotometers, balances, incubators, and environmental chambers.
- Coordinate calibration and maintenance activities with service providers.
- Act as a subject matter expert (SME) for validation processes and provide guidance to cross-functional teams.
- Conduct training sessions for end-users on validated systems and procedures.
Requirements :
