QA Compliance Specialist
2 weeks ago
We are seeking a highly skilled Quality Assurance Expert to join our team. This role plays a critical part in ensuring compliance with external regulatory requirements and industry best practices.
This position involves oversight of validation activities for equipment, utilities, processes, and software, as well as participation in broader Quality Assurance initiatives.
Key Responsibilities:- Validation & Quality Assurance: Coordinate, direct, and actively participate in validation and QA activities for site equipment, utilities, processes, and software.
- Ensure compliance with FDA, European cGMP, and GAMP standards.
- Develop, maintain, and execute the Site Validation Master Plan and Project Validation Plans.
- Generate validation protocols, reports, and investigations to meet cGMP standards.
- Implement corrective actions as identified through validation investigations.
- Create, review, and approve quality documents and test data.
- Manage validation, exception events, and change control processes.
- Maintain validation equipment records and ensure accurate tracking.
- Document all activities per cGMP requirements and update procedures to reflect current best practices.
- Bachelor's degree in Engineering or a scientific discipline.
- At least 3 years of experience in medical device plastics processing, moulding, or assembly operations.
- Strong communication (written and oral), presentation, and troubleshooting skills.
- Effective interpersonal and organizational skills.
- Ability to work independently and collaboratively in a team environment.
- Strong prioritization and multitasking abilities.
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