Top Skills:
• Bachelor’s degree (B.S.) in related field or equivalent.
• Five year’s related experience or equivalent in a Medical Device or FDA Regulated industry.
• Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, ISO 13485:2003 and ISO 9001 Standards
• Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
• Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills
Job description:
This position has responsibility and authority for:
• Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, Risk Assessments and Validation Summary Reports
• Analysis of current business processes to translate development documents into user requirements and functional design specifications
• Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis
• Documentation and remediation of deviations resulting from validations/qualifications.
• Utilizes established protocols to perform validation and qualification tests and provide detailed and accurate analysis of test results, identifying validation failures and areas of non-conformance
• Provide assistance and guidance in training co-workers on validation protocols and operating procedures.
• Oversees external validation resources that may be used in the validation project
• Author assigned Operating Procedures (SOPs & DOPs) and Policies to ensure compliance with Company policies and federal regulations.
• Support regulatory agency inspections/audits, as required.
• Must be familiar with cGMPs and current industry guidelines.
• Maintains awareness of regulatory requirements
