We are seeking an experienced and detail-oriented Quality Operations Specialist to join our team, focused on ensuring high standards of quality and compliance across our pharmaceutical production processes. This role emphasizes validation and change control activities, with a strong commitment to regulatory compliance within a GMP-regulated environment. The successful candidate will bring proven experience in validation and change management specifically within the pharmaceutical industry and will collaborate closely with cross-functional teams to uphold product quality and safety.
Requirements:
Bachelors degree in Life Sciences, Engineering, or a related technical field.
Minimum 3-5 years of experience in Quality Operations or Quality Assurance within the pharmaceutical industry, specifically with experience in validation and change control under GMP regulations.
Deep understanding of regulatory requirements (FDA, EMA, GMP) related to validation, change control, and quality systems in the pharmaceutical field.
Proven experience with IQ/OQ/PQ, risk-based validation, and managing change control processes in a pharmaceutical manufacturing environment.
Bachelors degree in Life Sciences, Engineering, or a related technical field.
Minimum 3-5 years of experience in Quality Operations or Quality Assurance within the pharmaceutical industry, specifically with experience in validation and change control under GMP regulations.
Deep understanding of regulatory requirements (FDA, EMA, GMP) related to validation, change control, and quality systems in the pharmaceutical field.
Proven experience with IQ/OQ/PQ, risk-based validation, and managing change control processes in a pharmaceutical manufacturing environment.
This position is open to all candidates.
