Senior Specialist - Quality & CSV

Job Description

CSV Management:

1.Assist in the planning, execution, and management of Computer System Validation (CSV) projects.

2.Prepare and review validation documentation such as URS, FS, IQ, OQ, PQ, validation plans, and reports.

3.Conduct validation activities to ensure compliance with GxP, FDA, and other relevant regulatory requirements.

4.Collaborate with cross-functional teams, including IT, QA, and operations, to ensure seamless implementation of validated systems.

5.Participate in risk assessments and gap analysis for computerized systems to ensure continuous compliance.

6.Ensure adherence to validation protocols, documenting any deviations and corrective actions.

7.Hands on experience to any Validation Software Applications

Quality Assurance:

1.Assist in the development and implementation of Quality Management Systems (QMS) related to CSV.

2.Ensure all Documentation processes, procedures, and systems comply with relevant regulatory standards.

3.Perform internal audits to verify compliance and identify areas for improvement.

4.Support CAPA (Corrective and Preventive Action) management and change control processes.

Sales and Business Development Support:

1.Collaborate with the presale & sales team to provide technical expertise during client meetings and presentations.

2.Assist in the preparation of proposals and presentations tailored to client requirements.

3.Identify new business opportunities within the Quality and CSV domain and provide input to the business development team.

4.Support client engagement activities by acting as a liaison between technical teams and customers.

5.Track and maintain the leads & Opportunities spreadsheet and report to the manager regularly.

Qualifications:

1. Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field.
2. 2-5 years of experience in Quality Assurance and Computer System Validation (CSV) within the life sciences industry.
3. Familiarity with regulatory guidelines (GxP, FDA, EMA, etc.) and validation standards.
4. Experience with validation software tools, automated testing, and risk management processes.
5. Strong understanding of QMS and compliance frameworks.
6. Knowledge of industry best practices in CSV documentation and procedures.
7. Experience in sales or business development in life sciences is a plus.
8. Life Sciences industry experience is strongly preferred.

Skills and Competencies:

1. Strong analytical and problem-solving skills.
2. Attention to detail and ability to work in a highly regulated environment.
3. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
4. Ability to manage multiple projects and deadlines simultaneously.
5. Proficiency in Microsoft Office Suite and validation software.

Willingness to learn and contribute to sales and client engagement activities