Senior Quality Assurance Specialist Role Overview
This key position oversees the entire validation process to ensure compliance with current regulatory requirements, cGMP, and company standards.
* Ensure quality oversight of qualification/validation activities.
* Review validation documentation and associated data.
* Provide QA oversight for events/deviations, investigations, and change evaluations.
* Maintain understanding of cGMP regulations and guidance.
* Coordinate QA validations activities.
Required Skills and Qualifications:
* Bachelor's degree in a scientific or engineering related field.
* At least 3 years of experience in a Quality Engineering/Quality Assurance/Quality Validations role.
* Strong technical knowledge and deep understanding of GxP regulations.
Key Responsibilities:
* Validation Activity Oversight.
* Documentation Review and Coordination.
* Change Evaluation and Investigation Management.
Knowledge and Skills Required:
* cGMP Regulations and Guidelines.
* Quality Engineering Principles.
* Project Coordination and Time Management.