
Validate Processes
1 week ago
Process Validation Expert
This is a fantastic opportunity to work in a cutting-edge facility with a leading company focused on developing innovative treatments for rare diseases.
Key Responsibilities- Perform process validation activities related to drug substance and drug products through defined clinical and commercial stages.
- Execute process validation activities, including protocol generation, execution, and final package preparation, related to the implementation of process changes and new processes.
- Assist with regulatory filings and answer questions from regulatory agencies.
- Develop and implement SOPs/Guideline documents with systemic procedural improvements.
Requirements:
- Experience in cGMP regulated manufacturing environment with knowledge or proficiency in process validation, process sciences and change control.
- Strong organisational and management skills to participate in multi-discipline project groups.
- Ability to communicate effectively with variable hierarchical audiences and defend approaches.
What You'll Achieve:
- Contribute to the development of life-changing treatments for individuals.
- Improve process efficiency and effectiveness.
- Enhance your career in a dynamic and innovative company.
Our Company Offers:
- A collaborative and supportive working environment.
- Ongoing training and professional development opportunities.
- Competitive compensation and benefits package.
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