Job Overview
The role of a Quality Assurance Specialist involves ensuring compliance with Good Manufacturing Practice (GMP) regulations. This position is responsible for managing quality-related activities, including batch release, document review, data integrity, change control, non-conformance investigations, and compliance auditing.
Duties:
* Support GMP activities from operational through to batch release.
* Partner with other departments to ensure effective completion of compliance programs.
* Implement improvements and procedures for change control and deviation management.
* Provide quality oversight of project activities, including batch release team improvements, data integrity, and system enhancements.
* Participate in inspections and audits by external parties.
* Execute duties as a key member of the QA team.
Requirements:
* Bachelor's degree in a scientific or technical discipline.
* At least 5 years of relevant work experience.
* Knowledge of FDA/EMEA regulatory requirements applicable to biologics and pharmaceuticals.
Additional Responsibilities:
* May require irregular domestic and international travel.
This is an excellent opportunity for individuals seeking a challenging role in quality assurance within a leading pharmaceutical organization. If you have a strong background in quality management and are passionate about ensuring compliance, we encourage you to apply.