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Chief System Validator
2 weeks ago
About the Position:
Our organization seeks a skilled professional to fill the role of Validation Engineer.
- Job Title : Validation Engineer
Key Responsibilities:
- Develop and implement effective strategies for validating computer systems and ensuring compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and prioritize system validation needs.
- Design and execute testing protocols to ensure the quality and reliability of computer systems.
- Provide training and support to employees on system validation procedures and best practices.
- Conduct regular audits and assessments to ensure ongoing compliance with regulatory requirements.
Required Skills and Qualifications:
- 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
- Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
- Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
- Ability to work on complex projects with general direction and minimal guidance.
- Ability to handle multiple projects and meet deadlines.
- Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
The ideal candidate will have excellent analytical skills and be able to effectively communicate with cross-functional teams. They must also be self-motivated and proactive in their approach to problem-solving.