Job Description
Role Overview
We are seeking a dedicated Quality Operations Engineer to join our pharmaceutical operations team. The successful candidate will play a key role in managing change controls and providing quality oversight for equipment qualification activities, ensuring compliance with regulatory standards and internal quality systems. Key Responsibilities Change Controls
: Lead and manage change control processes, ensuring timely evaluation, documentation, and implementation in alignment with GMP requirements. Equipment Qualification Oversight
: Provide quality oversight for equipment qualification activities (IQ/OQ/PQ), ensuring adherence to validation protocols and regulatory expectations. Quality Compliance
: Ensure compliance with company SOPs, industry guidelines, and regulatory requirements (e.g., FDA, EMA, PIC/S). Cross-Functional Collaboration
: Partner with engineering, manufacturing, and validation teams to support continuous improvement initiatives. Documentatio...
We are seeking a dedicated Quality Operations Engineer to join our pharmaceutical operations team. The successful candidate will play a key role in managing change controls and providing quality oversight for equipment qualification activities, ensuring compliance with regulatory standards and internal quality systems. Key Responsibilities Change Controls
: Lead and manage change control processes, ensuring timely evaluation, documentation, and implementation in alignment with GMP requirements. Equipment Qualification Oversight
: Provide quality oversight for equipment qualification activities (IQ/OQ/PQ), ensuring adherence to validation protocols and regulatory expectations. Quality Compliance
: Ensure compliance with company SOPs, industry guidelines, and regulatory requirements (e.g., FDA, EMA, PIC/S). Cross-Functional Collaboration
: Partner with engineering, manufacturing, and validation teams to support continuous improvement initiatives. Documentatio...