
Pharmaceutical Quality Specialist
1 dia atrás
This role is responsible for ensuring the quality and compliance of pharmaceutical manufacturing processes and equipment.
The successful candidate will have a strong understanding of commissioning, qualification, and validation protocols, as well as experience with risk assessments and gap analyses.
Key Responsibilities include:
- Developing and executing commissioning, qualification, and validation protocols for new and existing equipment and processes.
- Conducting risk assessments and gap analyses to identify areas for improvement in compliance and quality.
- Performing equipment and process qualifications, including installation, operational, and performance qualifications.
- Reviewing and approving validation documentation, including protocols, reports, and deviations.
- Collaborating with cross-functional teams, including engineering, manufacturing, and quality, to ensure compliance with regulatory requirements and company standards.
- Troubleshooting equipment and process issues and providing technical support to resolve them.
- Participating in audits and inspections, both internal and external, and assisting with implementing corrective and preventative actions.
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