Senior Specialist
3 weeks ago
Job Title: Senior Specialist
Job Summary
Smart IMS Inc. is seeking a motivated Senior Specialist to join our team. The ideal candidate will have a strong background in Quality Assurance and Computer System Validation (CSV) within the life sciences industry.
Key Responsibilities
- Assist in the planning, execution, and management of CSV projects.
- Prepare and review validation documentation, including URS, FS, IQ, OQ, PQ, validation plans, and reports.
- Conduct validation activities to ensure compliance with GxP, FDA, and other relevant regulatory requirements.
- Collaborate with cross-functional teams, including IT, QA, and operations, to ensure seamless implementation of validated systems.
- Participate in risk assessments and gap analysis for computerized systems to ensure continuous compliance.
- Ensure adherence to validation protocols, documenting any deviations and corrective actions.
- Hands-on experience with validation software applications.
Requirements
- Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field.
- 2-5 years of experience in Quality Assurance and CSV within the life sciences industry.
- Familiarity with regulatory guidelines (GxP, FDA, EMA, etc.) and validation standards.
- Experience with validation software tools, automated testing, and risk management processes.
- Strong understanding of QMS and compliance frameworks.
- Knowledge of industry best practices in CSV documentation and procedures.
- Experience in sales or business development in life sciences is a plus.
- Life sciences industry experience is strongly preferred.
Benefits
- Opportunity to work in a dynamic and growing company.
- Collaborative and supportive team environment.
- Professional development and growth opportunities.
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