
Sterile Products Validation Manager
3 days ago
Aseptic Process Specialist
">Job Description:We are seeking a highly skilled Aseptic Process Specialist to join our team. In this role, you will be responsible for ensuring the integrity of aseptic process controls throughout our manufacturing operations.
- Develop and execute validation protocols to ensure aseptic process control equipment is functioning correctly.
- Review and approve media fill study results to validate aseptic processing capabilities.
- Collaborate with cross-functional teams to implement corrective actions based on environmental monitoring data.
- Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for equipment and utilities.
- Prepare and review cleaning validation protocols and reports to ensure adequacy and suitability for product changeover.
To succeed in this role, you should possess:
- Expert knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in QMS tools and software.
You should hold a Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, or a related field.
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