Validation Lead

3 weeks ago

Bengaluru, Karnataka, India Qualitest Full time
Job Description

Key Responsibilities:

1. GxP Compliance: Lead the validation team in ensuring all processes adhere to GxP standards, including GLP, GCP, and GMP, and maintain compliance with regulatory requirements

2. Validation Strategy: Develop and implement validation strategies, including risk-based approaches, to ensure systems and processes meet regulatory and industry standards

3. Team Management: Supervise and mentor validation engineers/specialists, providing guidance on GxP, validation testing, and CSV best practices.

4. Computer System Validation (CSV): Oversee the development, review, and approval of CSV documentation, including validation plans, protocols, reports, and risk assessments.

5. Product Knowledge: Leverage in-depth knowledge of life sciences and Healthcare products, including eQMS, eTMF, RIM, CTMS, Argus, RAVE EDC, to guide validation efforts and support product implementation.

6. Regulatory Compliance: Stay abreast of regulatory changes and ensure all processes, systems, and documentation comply with current regulations.

7. Collaboration: Work closely with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure validation activities align with project goals.

8. Training: Conduct training sessions for team members and stakeholders on GxP, validation processes, and CSV methodologies.

9. Project Management: Manage validation projects, ensuring they are completed on time, within scope, and meet quality standards.

Key Skills:

1. Leadership and Management:

2. Proven experience in leading and managing validation teams.

3. Strong project management skills with the ability to manage multiple projects simultaneously.

4. GxP Compliance.

5. Extensive experience with GLP, GCP, and GMP.

6. Knowledge of regulatory requirements and industry standards

7. Strong understanding of quality management systems in R&D environments.

8. Validation Testing: Expertise in planning, executing, and documenting validation tests. Familiarity with various validation methodologies and tools.

9. Computer System Validation (CSV):

Deep knowledge of CSV principles and documentation.

Experience in risk-based validation approaches. Life Sciences/Healthcare Product Knowledge .

Hands-on experience with eQMS, eTMF, RIM, CTMS, Argus, RAVE EDC or similar systems.

Ability to implement best practices for life sciences product validation.

Qualifications:

- Bachelor s or Master s degree in a relevant field.
- Minimum of 7 years of experience with a focus on GxP, validation testing, and CSV.
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration abilities.
- Ability to lead, mentor, and motivate a team.
- Prepare estimation, collaborate with IT, Business and cross functional Team.

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