Csv Specialist

Key Accountabilities:

- Prepare and execute validation protocols for range of production, laboratory equipment, facilities and utilities.
- Ensure validation compliance is maintained in accordance with the site validation master plan.
- Maintain validation compliance within the department through maintaining validation documentation.
- Ensure all activities are carried out in a safe manner and comply with the site safety standards.
- Perform periodic reviews on equipment and systems.
- Support the site in maintaining its compliance objectives through timely closure of CAPA, Deviations and Change control Tasks.
- Support other members of the validation team where required.
- Active contribution to the meetings.
- Proactive and smart contribution to the development of the validation strategies. Perform other duties as assigned.
Education-Required:

- Degree in Science.
Language-Required:

- English.
Work Experience-Advanced Level:

- Broad experience of validation lifecycle projects.
- Broadly experienced in cell banking and analytical services departments.
- Able to manage projects.
- Experienced in created and managed documents, Experience in Quality records. Comprehensive understanding of GMP in Biopharmaceutical - EU and USA rules and guidelines.
- Comprehensive understanding of validation principles and practices: risk-based approach.
- Pharmaceutical Quality systems including change control, deviation, CAPAs.
Entry Level:

- Knowledge and understanding of manufacturing operations; fermentation, purification and controlled storage.

Index Recruitment Ltd is acting as an Employment Business in relation to this vacancy.