Csv Executive

5 days ago

Hyderabad Telangana, India Katalyst Healthcares & Life Sciences Full time

**Responsibilities**:

- Assist in the planning, execution, and management of Computer System Validation (CSV) projects.
- Prepare and review validation documentation such as 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 to any Validation Software Applications.
- Assist in the development and implementation of Quality Management Systems (QMS) related to CSV.
- Ensure all Documentation processes, procedures, and systems comply with relevant regulatory standards.
- Perform internal audits to verify compliance and identify areas for improvement.
- Support CAPA (Corrective and Preventive Action) management and change control processes.
- Collaborate with the pre-sale & sales team to provide technical expertise during client meetings and presentations.
- Assist in the preparation of proposals and presentations tailored to client requirements.
- Identify new business opportunities within the Quality and CSV domain and provide input to the business development team.
- Support client engagement activities by acting as a liaison between technical teams and customers.
- Track and maintain the leads & Opportunities spreadsheet and report to the manager regularly.

**Requirements**:

- Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field.
- 2-5 years of experience in Quality Assurance and Computer System Validation (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.
- Strong analytical and problem-solving skills.
- Attention to detail and ability to work in a highly regulated environment.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Ability to manage multiple projects and deadlines simultaneously.
- Proficiency in Microsoft Office Suite and validation software.
- Willingness to learn and contribute to sales and client engagement activities.

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