QC Lab Equipment Qualification Support
Validation & Engineering GroupRÃo Piedras, Puerto Rico, United States
Posted April 20, 2021
Full Time
About the Company
Validation & Engineering Group provides compliance, validation, and engineering services for pharmaceutical, medical device, and biotech companies.
Job Description
Development and execution of Laboratory Equipment Validation, creation of validation plans, risk assessments, and documentation packages. Validation experience in computer systems and GMPs regulations required.
Requirements
- Bachelor Degree in Chemistry or related discipline
- Experience developing Validation Plans, Risk Assessments, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs
- Validation Experience in Computer Systems
- 21 CFR Part 11 practical knowledge
- Strong knowledge in GMPs regulations
- Technical Writing Experience
- Validation expertise in: Sterilization, Kaye Validator & Data loggers, Process Validation, Equipment Qualification, Re-qualification, Computer System Validation