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.