Job Description
We are seeking a Quality Engineer to support our operations department in ensuring compliance with GMP/GDP requirements for an Aseptic fill finish facility. The successful candidate will work closely with various departments to ensure adherence to regulations, industry best practices, internal policies and procedures.
The role involves developing operational procedures for best practice and regulatory compliance; conducting risk assessments on processes and equipment. The candidate will also generate reports and data for Annual Product Quality Reviews, Regulatory submissions, customer complaint investigations, and periodic reviews.
Responsibilities:
* Ensure compliance with internal/external regulatory requirements;
* Develop operational procedures for best practice and regulatory compliance;