QMS Manager - Non Product Software Validation

Job Title

QMS Manager - Non Product Software Validation

Job Description

Job Title: QMS Manager - Non Product Software Validation

Job Responsibilities:

• Develop, implement, and maintain software validation procedures and standards

• Ensure non product software validation lifecycle is followed compliantly, including planning, risk assessments, testing and periodic review

• Ensure validation deliverables meet regulatory, quality and business requirments
• Prepares for and supports internal and external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings.
• Facilitates cross-functional collaboration to resolve quality-related issues, working closely with other departments to ensure alignment and effective problem-solving.
• Oversee quality assurance processes related to computerized systems and software applications
• Review and approve validation documentation, including requirements specifications, test protocols, test reports, and validation summaries
• Drives continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to improve overall quality performance and operational efficiency.
• Addresses difficult to moderately complex issues or problems, requiring the evaluation of identifiable factors, following established processes and operational policies in selecting methods and techniques for obtaining solutions.
• Guides and mentors, the validation project team members, actively contributing to employee development in Validation Lifecycle requirements
• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.

Minimum required Education:

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

Minimum required Experience: