Job Title: Validation Specialist
The primary focus of this role is to develop and implement validation strategies for various equipment, systems, and processes within the quality management framework.
Key Responsibilities:
* Design and execute validation plans, protocols, and reports in compliance with regulatory requirements.
* Collaborate with cross-functional teams to provide validation inputs and drive operational activities forward.
* Liaise with external vendors to obtain validation requirements and specifications.
* Develop and manage validation projects, including master validation plans.
* Ensure ongoing compliance with Good Manufacturing Practices (GMP) and regulatory directives.
* Conduct risk assessments and participate in quality audits.
* Apply Lean 6 Sigma tools to optimize problem-solving and process improvement.
Required Qualifications:
* Strong understanding of quality management systems and regulatory requirements.
* Excellent communication and collaboration skills.
* Ability to work independently and as part of a team.
* Proficiency in Lean 6 Sigma methodologies.
Benefits:
* Opportunity to work in a dynamic and innovative environment.
* Professional growth and development opportunities.
* Competitive compensation and benefits package.