Validation Assurance Specialist
4 days ago
Job Title: Validation Assurance Specialist
About Us:
Quasar Medical (Singapore) Pte. Ltd. is a leading medical device manufacturer dedicated to delivering innovative solutions that improve patient outcomes.
About the Role:
We are seeking an experienced Validation Assurance Specialist to join our team in Singapore. As a key member of our quality assurance department, you will be responsible for ensuring that our medical devices and manufacturing processes meet required quality standards and regulatory requirements.
About You:
To succeed in this role, you should have a strong background in validation and quality assurance, with experience in leading and executing validation activities, including equipment, process, test method, and software validation.
Responsibilities:
- Validation Planning and Execution:
- Develop and maintain validation protocols and procedures
- Lead execution of validation activities, including IQ, OQ, and PQ
- Perform risk assessments to identify critical areas and establish validation strategies
- Ensure re-validation and periodic review is conducted in a timely manner
Documentation and Reporting:
- Prepare and review detailed validation documentation
- Maintain and update Master Validation Plan as required
- Authorize and approve validation documents and reports prepared by other team members
- Maintain accurate and complete records of validation activities and results
Compliance and Quality Assurance:
- Ensure validation activities comply with FDA regulations, ISO standards, and other relevant guidelines
- Support internal and external audits and regulatory inspections
- Investigate and resolve validation-related issues, deviations, and non-conformities
Cross-functional Collaboration:
- Collaborate with engineering, manufacturing, and quality assurance teams
- Provide validation expertise and exercise authority in decision-making
- Oversee and support training of personnel on validation procedures and best practices
Continuous Improvement:
- Identify opportunities for process improvements and efficiency gains within validation scope
- Stay current with industry trends, technological advancements, and regulatory changes related to validation and medical device manufacturing
- Implement improvements and best practices within validation framework
What We Offer:
$120,000 - $150,000 per annum, depending on experience, plus benefits and career development opportunities in a dynamic and growing company.
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