Chief Quality Assurance Officer

1 week ago

Bengaluru, Karnataka, India beBeeValidationlead Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Validation Lead

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As a senior quality professional, you will be responsible for overseeing the validation process to ensure that all systems and processes adhere to regulatory requirements. This includes GLP, GCP, and GMP standards.

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Key Responsibilities:

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  • GxP Compliance: Lead the team in ensuring that all processes meet regulatory requirements and maintain compliance with GxP standards.">
  • Validation Strategy: Develop and implement risk-based validation strategies to ensure systems and processes meet regulatory and industry standards.">
  • Team Management: Supervise and mentor engineers/specialists, providing guidance on GxP, validation testing, and CSV best practices.">
  • Computer System Validation (CSV): Oversee the development, review, and approval of CSV documentation, including validation plans, protocols, reports, and risk assessments.">
  • Product Knowledge: Leverage in-depth knowledge of life sciences and healthcare products to guide validation efforts and support product implementation.">
  • Regulatory Compliance: Stay abreast of regulatory changes and ensure that all processes, systems, and documentation comply with current regulations.">
  • Collaboration: Work closely with cross-functional teams to ensure validation activities align with project goals.">
  • Training: Conduct training sessions for team members and stakeholders on GxP, validation processes, and CSV methodologies.">
  • Project Management: Manage validation projects, ensuring they are completed on time, within scope, and meet quality standards.">
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Required Skills and Qualifications:

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  • Leadership and Management: Proven experience in leading and managing validation teams.">
  • Project Management: Strong project management skills with the ability to manage multiple projects simultaneously.">
  • GxP Compliance: Extensive experience with GLP, GCP, and GMP.">
  • Regulatory Requirements: Knowledge of regulatory requirements and industry standards.">
  • Quality Management Systems: Strong understanding of quality management systems in R&D environments.">
  • Validation Testing: Expertise in planning, executing, and documenting validation tests.">
  • Computer System Validation (CSV): Deep knowledge of CSV principles and documentation.">
  • Lifesciences/Healthcare Product Knowledge: Hands-on experience with eQMS, eTMF, RIM, CTMS, Argus, RAVE EDC or similar systems.">
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Benefits:

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This role offers opportunities for growth and development as a senior quality professional. If you have a background in lifesciences and healthcare, and are passionate about quality management systems, this could be the perfect opportunity for you.

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Keyword: ValidationLead

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