Performance and Validation Expert
4 weeks ago
Ipsen Biopharm Ltd is a dynamic and innovative biopharmaceutical company focused on delivering high-quality products and services to our customers.
We are seeking a skilled Validation and Quality Assurance Specialist to join our team and contribute to our mission of making a positive impact on people's lives.
In this role, you will be responsible for supporting the engineering team in defining, executing, and reporting on validation maintenance activities associated with facilities, utilities, and process equipment.
You will perform routine system reviews, hands-on requalification activities, and ensure optimal performance and output.
Additionally, you will contribute to a risk-based validation approach through participation in risk assessment and the implementation of Continuous Improvement initiatives.
Key responsibilities
- Define, execute, and report qualification and re-qualification studies to maintain the qualified status of facilities, utilities, equipment, and processes.
- Subject Matter Experts for specific validation activities, including presenting packages to internal and external auditors.
- Investigate and resolve non-conformances encountered during requalification and periodic review activities.
- Contribute to a risk-based validation approach through participation in risk assessment and the implementation of Continuous Improvement initiatives.
Key requirements
- Prior experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
- Good understanding of validation lifecycles and current regulatory requirements.
- Knowledge of industry guidance and standards associated with validation activities.
- Experienced in the execution of qualification and validation activities.
- Appreciation for technical, compliance, and practical understanding of specific qualification activities.
- Basic understanding of quality risk assessment principles and tools.
- Competent in the generation and review of technical documentation.
Why Ipsen Biopharm Ltd?
- We are a growing and dynamic company with a wide range of opportunities and exciting challenges.
- We are committed to Diversity & Inclusion and have a fantastic culture and working environment.
- We have a genuine focus on the environment and sustainability.
- We offer competitive salaries and an enhanced benefits package.
- We are a proud company that directly impacts and changes lives for the better.
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