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Validation Specialist
2 months ago
We are seeking a highly skilled Validation Specialist to join our team at GForce Life Sciences.
The successful candidate will be responsible for developing and implementing validation plans, protocols, and reports to ensure compliance with FDA regulations and industry standards.
Key Responsibilities- Develop and approve validation plans, IQ, OQ protocols, trace matrices, risk assessments, and validation summary reports.
- Analyze 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.
- Document and remediate deviations resulting from validations/qualifications.
- Utilize 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.
- Oversee 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.
- Maintain awareness of regulatory requirements.
- Bachelor's degree (B.S.) in a related field or equivalent.
- Five years of 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.
