Data Validation Specialist
2 days ago
Job Summary:
A critical role exists for an experienced Data Validation Specialist in the field of computerised equipment and systems validation in sterile products manufacturing. They are responsible for collaborating with cross-functional teams to ensure all computerised equipment and systems meet regulatory requirements.
Main Responsibilities:
- Develop and execute comprehensive validation protocols for computerised equipment and systems.
- Create documentation, including reports and protocols, to support validation activities.
- Collaborate with cross-functional teams to resolve CSV issues and ensure compliance with regulations.
- Design and implement validation studies for manufacturing and control equipment.
- Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation.
- Maintain up-to-date knowledge of relevant quality and compliance regulations, including GAMP and ISPE Baseline guides.
Requirements:
- Degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical, Mechanical, or Electrical).
- Post-graduate studies as appropriate to augment primary Degree.
- 3-5 years experience working in a Healthcare manufacturing environment, ideally in the pharmaceutical sector.
- 2-3 years experience in a validation environment.
- Project management experience.
Benefits:
This role offers opportunities for career growth and development, working with a dynamic team, and contributing to high-quality products that make a difference in people's lives.
Why Choose Us:
We offer a collaborative work environment, competitive compensation package, and excellent benefits.
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