Overview
We are seeking a Quality Operations Engineer to join our pharmaceutical operations team. This role is critical in ensuring compliance with Good Manufacturing Practice (GMP) standards, supporting laboratory and production activities, and driving continuous improvement in quality systems. The successful candidate will play a key role in equipment lifecycle management, process oversight, and operational excellence.
Key Responsibilities
- Oversee qualification, requalification, relocation, decommissioning, and retirement of GMP laboratory and production equipment.
- Ensure compliance with GMP, regulatory, and company quality standards across all operations.
- Support daily quality operations, including deviation management, CAPA (Corrective and Preventive Actions), and change control.
- Collaborate with cross-functional teams (Quality Assurance, Engineering, Manufacturing, and Laboratory staff) to ensure smooth execution of projects.
- Conduct risk assessments and provide technical input for equipment and process changes.
- Maintain accurate documentation for audits, inspections, and regulatory submissions.
- Drive continuous improvement initiatives to enhance efficiency and compliance in quality operations.
Qualifications
- Bachelor's degree in Engineering, Pharmaceutical Sciences, or related discipline.
- Strong knowledge of GMP regulations and pharmaceutical industry standards.
- Experience in equipment lifecycle management and quality operations within a GMP-regulated environment.
- Excellent documentation, organizational, and problem-solving skills.
- Ability to work independently and collaboratively in cross-functional teams.
Preferred Attributes
- 3-5 years of experience in pharmaceutical quality operations or engineering.
- Familiarity with laboratory and production equipment such as HPLC, spectrometers, controlled temperature units, centrifuges, and incubators.
- Strong communication skills with the ability to influence and support operational teams.
- Proactive mindset with a focus on compliance and continuous improvement.
